mortality influenced by sepsis bundle compliance and
TRANSCRIPT
Belmont UniversityBelmont Digital Repository
DNP Scholarly Projects School of Nursing
4-15-2019
Mortality Influenced by Sepsis Bundle Complianceand Initial Lactic Acid in Severe Sepsis and SepticShockEvelyn GeorgeBelmont University
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Recommended CitationGeorge, Evelyn, "Mortality Influenced by Sepsis Bundle Compliance and Initial Lactic Acid in Severe Sepsis and Septic Shock" (2019).DNP Scholarly Projects. 15.https://repository.belmont.edu/dnpscholarlyprojects/15
Running head: SEPSIS BUNDLE AND LACTIC ACID 1
Mortality Influenced by Sepsis Bundle Compliance and Initial Lactic Acid in Severe Sepsis and
Septic Shock
Evelyn George
Scholarly Project Advisor: Dr. Linda Wofford
Scholarly Project Team Members: Dr. Erin Shankel, Dr. David Phillippi
Date of Submission: April 15, 2019
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Table of Contents
Abstract 4
Introduction and Background 5
Problem Statement 6
Purpose 7
Review of Evidence 7
Defining Sepsis, Severe Sepsis, Septic Shock 7
Sepsis Bundle 8
Sepsis Bundle Compliance Related to Mortality Rates 9
Lactic Acid Related to Mortality Rates 9
Age and Sepsis Bundle 11
Theoretical Model 12
Structure 12
Process 13
Outcomes 13
Application 13
Project Design 14
Clinical Setting 14
Project Population 16
Sources of Data 16
Data Collection Process 17
Statistical Analysis 18
Results 18
Sample Characteristics 18
Overall Sepsis Bundle Compliance and Mortality 19
Lactic Acid and Mortality 19
Older Individuals and Mortality 19
Discussion 20
Conclusion 24
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References 25
Appendix 34
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Abstract
Sepsis, a life-threatening infection killing 270,000 yearly, is a concern to health care providers,
policy makers, and patients due to its high volume and increasing cost. Patients older than 64
years have a higher occurrence of sepsis and greater mortality risk. The Surviving Sepsis
Guidelines (SSG) recommends the use of the three-hour bundle that standardizes care to
decrease cost, morbidity, and mortality. The three-hour bundle includes two treatments,
intravenous fluids and antibiotics, and two tests, blood cultures and lactic acid level. One bundle
element, lactic acid level, is associated with higher mortality rates, although only a few studies
exist. The project purpose was to compare the influence of the three-hour sepsis bundle
completion and the initial lactic acid level on mortality rates in adults in an emergency
department over a two-year period. The Donabedian quality of care framework guided the
project related to structure, process, and outcome. Analysis of data from a retrospective chart
review of 341 charts determined the association between three-hour sepsis bundle compliance
and mortality rates. Individuals who received the three-hour bundle elements had lowered
mortality rates and those with higher lactic acid had increased odds of mortality. There was no
significance between mortality rates of older individuals who received the three-hour bundle
elements and those who did not. The findings of this project confirm completing the three-hour
bundle and improving current processes in a specific emergency room positively impact
mortality rate.
Keywords: three-hour sepsis bundle, lactic acid, mortality rate, emergency department
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Introduction and Background
According to Centers for Disease Control and Prevention (2018), sepsis affects 1.7
million adults annually in the United States and 270,000 die as a result of sepsis each year.
Sepsis is defined as the body’s reaction to an infection. Sepsis can progress into organ
dysfunction with a high risk of mortality leading to severe sepsis and septic shock (Rhodes et al.,
2017; Shah, Sterk, & Rech, 2018). Although the immune system is equipped to fight infection in
healthy individuals, treatments such as administration of intravenous fluids, antibiotics, and tests
such as blood cultures and lactic acid levels, can improve survival rates.
Sepsis is a concern for health care providers, policy makers, and patients due to the high
volume of cases and high cost. Sepsis prevalence is expected to increase in the coming years,
with a projected incidence of 1 million cases by year 2020 (Bang & Doty, 2009). According to
Agency for Healthcare Research and Quality (AHRQ), septicemia is the sixth most common
reason for hospitalization in the United States, affecting one of every 23 hospitalized patients
(AHRQ, 2012). Between 2005 and 2010, patients with a primary diagnosis of septicemia
contributed to a 71% increase in hospitalizations (Sutton & Friedman, 2013). Because longer
hospitalizations means higher cost, the projected cost of septicemia in the U.S healthcare system
was $20.3 billion in 2011 and increased to $24.3 billion in 2013 in the most recently published
data, which makes it the most expensive condition treated in the U.S hospitals (Torio &
Andrews, 2013; Torio & Moore, 2016)
Sepsis mortality is a serious concern in addition to high volume and increasing cost.
From 2009 to 2014, sepsis accounted for 6% of hospitalization, but 15% of hospital deaths (Rhee
et al., 2017). A 2014 study, including 2.9 million patients from 409 hospitals diagnosed with
sepsis, reported that 1.7 million hospitalizations in the U.S occurred due to sepsis with 270,000
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sepsis related deaths (Rhee et al., 2017). Medicare patients and patients older than 65 diagnosed
with sepsis have not only higher incidence, but also higher mortality risk when compared to a
younger population (Starr & Saito, 2014; Sutton & Friedman, 2013). In order to decrease sepsis
mortality, the Surviving Sepsis Campaign established Surviving Sepsis Guidelines (SSG)
recommending the use of a three-hour bundle which includes two treatments, intravenous fluids
and antibiotics, and two tests, blood cultures and lactic acid level (Rhodes et al., 2017; Society of
Critical Care Medicine, 2015). Additionally, as a quality process measure to address sepsis cost,
morbidity and mortality. The SSG facilitated timely standardized responses to sepsis patients to
decrease cost, decrease morbidity, and decrease mortality through the use of sepsis bundle.
One of the bundle elements, lactic acid level, is related to higher mortality rates in
patients admitted for sepsis and other critical illness (Park et al, 2018). Sinkovic, Markota,
Fluher, and Rehar (2013) performed a retrospective cohort analysis of 102 patients admitted with
sepsis and septic shock in medical ICU from 2008 – 2010 in which, increased levels of lactic
acid reliably predicted patients at higher risk of dying from sepsis and septic shock. However,
according to Liu et al (2013), sepsis patients with intermediate lactate values (less than four
mmol/L) had increased hospital admissions and higher 30-day mortality. Although the three-hour
sepsis bundle does have criteria to assess lactic acid level, the predictability of lactic acid level
on mortality rate needs further study.
Problem Statement
Sepsis is an alarming issue for the healthcare community because of high volume, cost,
morbidity, and mortality. Sepsis mortality rate can be positively influenced through compliance
of the sepsis bundle. Meanwhile, there is a literature gap in the study of mortality rate when
comparing three-hour sepsis bundle compliance and initial lactic acid level in sepsis patients.
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Purpose
The purpose of this quality improvement project was to compare if the three-hour sepsis
bundle compliance and initial lactic acid level influence mortality rate in adults diagnosed with
severe sepsis and septic shock in one ED over a two-year period. Through this project, the results
may reinforce the importance of sepsis bundle compliance in the ED and may highlight the
significance of the initial lactic acid measurement. The project may support the need for
standardized treatment in order to increase survival rates. The project findings will be
generalizable to patients diagnosed with sepsis who arrive to an ED. The author hypothesizes:
(a) Individuals who receive the three-hour bundle elements will have lower rates of
mortality compared to individuals who did not receive the three-hour bundle elements.
(b) Individuals with higher initial lactic acid level for diagnosis will have higher rates of
mortality compared to individuals who have decreased initial lactic acid.
(c) Older individuals who receive all the three-hour elements will have lower mortality
rates compared to who did not receive all of the three-hour bundle elements.
Review of Evidence
Defining Sepsis, Severe Sepsis, Septic Shock
Bone et al., (1992) conducted a landmark study that classified sepsis as the manifestation
of the body’s response to an infection or lack of infection and named it systemic inflammatory
response syndrome (SIRS). SIRS symptoms include temperature (greater than 38° Celsius or
100.4° Fahrenheit or less than 36° degrees Celsius 96.8° Fahrenheit), tachycardia (greater than
90 beats per minute), tachypnea, (greater than 20 breaths per minute), a change in white blood
cell count (greater than 12,000/cu mm) and a neutrophil count (less than 4,000/cu mm or 10%
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immature neutrophils). Any two SIRS symptoms in a patient result in a diagnosis of sepsis (Bone
et al, 1992; Cawcutt & Peters, 2014).
Sepsis can progress into severe sepsis and septic shock. “Severe sepsis” is defined as an
organ dysfunction and “septic shock” is defined as persistent induced hypotension despite fluid
resuscitation (Dellinger et al., 2013; Rhodes et al., 2017; Singer et al., 2016). This definition had
remained unchanged over two decades, until recently. In 2016, The Society of Critical Care
Medicine (SSCM) and the European Society of Intensive Care Medicine (ESICM) revised
definitions through supporting evidence and recommended elimination of the term “severe
sepsis” (Singer et al., 2016). For the purposes of this project and due to prior literature that was
published using prior definitions, “severe sepsis” and “septic shock” will be the terms used.
Sepsis Bundle
In 2002, the SSCM and the ESICM launched goals to increase septic awareness, improve
diagnosis and treatment, educate health care providers, and develop management guidelines to
reduce sepsis mortality (Makic & Bridges, 2018). In 2004, SSC partnered with the Institute of
Healthcare Improvement (IHI) along with panel experts, to develop two practice bundles that
included interventions in the first six hours, the resuscitation bundle, and, within 24 hours, the
management bundle (Marshall, Dellinger & Levy, 2010). After 2004, the resuscitation bundle
was renamed the three-hour bundle and the management bundle as the six-hour bundle (Society
of Critical Care Medicine, 2015). The SSC guidelines are revised every four years and the latest
revision was accomplished in 2016 (Makic & Bridges, 2018; Rhodes et al., 2017).
This project focused on the three-hour bundle elements. The three-hour bundle consists
of two tests, a lactic acid level and blood cultures prior to administration of antibiotics, and two
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treatments, administration of broad-spectrum antibiotics and intravenous fluids (Society of
Critical Care Medicine, 2015).
Sepsis Bundle Compliance Related to Mortality Rates
Sepsis bundle compliance improves patient outcomes (Dellinger et al., 2013; Rhodes et
al., 2017; Seymour et al., 2017). An all-or-none phenomenon is applied to the sepsis bundle
which requires all elements of the bundle to be accomplished in order to achieve bundle
compliance (Marshall et al., 2010). The largest study following the 2004 SSC guidelines
examined the relationship between sepsis bundle compliance and mortality. Levy et al (2015)
conducted a 7.5 year study with 29,470 patients from 218 hospitals in the United States, Europe,
and South America who met the criteria for severe sepsis and septic shock to determine the
association between sepsis bundle compliance and mortality. Overall mortality was lowered at
highly compliant sites (29.0%) compared to low compliance sites (38.6%); Overall hospital
mortality rate dropped 0.7% for every three month participation (p <0.001) (Levy et al., 2015).
Rhodes et al (2015) also conducted another global study with 618 hospitals from 62 countries
with patients presenting with severe sepsis and septic shock. The overall three-hour compliance
was associated with lower hospital mortality than non-compliance along with 40% reduction in
dying at the hospital when compliant with either three or six-hour bundle (Rhodes et al., 2015).
Bundle compliance changes patients’ outcomes globally in populations from ED, medical
surgical wards, and intensive care units (ICU) (Levy et al., 2015; Nguyen et al., 2011; Rhodes et
al., 2015).
Lactic Acid Related to Mortality Rates
Measuring lactic acid levels is one of the four elements of the three-hour sepsis bundle.
Lactic acid accumulates in the body due to an increase of lactic production, diminished use, and
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clearance of lactic or both which is a common cause for hyperlactemia in sepsis (Suetrong &
Walley, 2016). Hyperlactemia, elevated lactic acid, four mmol/L or higher is one criterion to
diagnose severe sepsis (Dellinger et al., 2013). Two-thirds of patients with severe sepsis or shock
had elevated lactate concentrations from the findings of Surviving Sepsis Campaign Database
(Casserly et al., 2015). There are ways to decrease initial lactic acid to decrease morality. In
septic patients decreasing initial lactic acid with hemodynamic resuscitation strategies such as
fluid administration is a successful strategy to impact mortality (Liu et al., 2013, Suetrong &
Walley, 2016).
Mikkelsen et al. (2009) evaluated the association between initial serum lactate level and
mortality rate in patients presenting to the ED with severe sepsis through a retrospective cohort
of patients from January 2005 to December 2006. The study confirmed that lactic acid level is
associated with mortality independent of organ dysfunction and shock in patients admitted to the
ED (Mikkelsen et al., 2009). However, since this study was published, SSG has updated
guidelines multiple times. The authors only focused on initial lactic acid levels and mortality
rates and neglected compliance of sepsis bundle along with this finding. Though studies establish
lactic acid levels and persistent hyperlactemia are associated with adverse outcomes in sepsis,
evidence has failed to compare noncompliance sepsis bundle and lactic acid levels (Khosravani
et al., 2009, Liu et al., 2013, Nguyen et al., 2011, Puskkarich, Illich, & Jones, 2014, Puskkarich
et al., 2013, Song et al., 2012, Toraman et al., 2004). With updated guidelines, new studies need
to compare the impact of three-hour sepsis bundle compliance and initial lactic acid levels on
mortality.
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Age and Sepsis Bundle
The aging population plays a significant role in the increasing rates of sepsis. In the last
10 years in the United States, the population aged 65 years and older increased from 37.2 million
in 2006 to 49.2 million in 2016 (33% increase) and is anticipated to almost double to 98 million
in 2060 (Administration of Aging, 2018). With increased age, the body’s immune response to
infection is reduced and puts older individuals at higher risk for developing infection (Rowe &
McKoy, 2017). Stoller et al. (2015) found sepsis prevalence increased from 346 per 100,000
persons in 2008 to 436 per 100,000 persons in 2012. The mean age of the patients was 69 years
in 2008 and 68 years in 2012 (Stoller et al., 2015).
Older adults have increased risk factors for deterioration from sepsis than younger
patients due to decrease in organ function, immune function, and other comorbidities (Girard,
Opal & Ely, 2005). Over the past several decades, the sepsis bundle has provided standardized
care in both young adults and elderly patients (Makic & Bridges, 2018; Rhodes et al., 2015;
Rhodes et al., 2017). Negret-Delgado et al. (2016) determined the adherence of the sepsis bundle
comparing groups over and under 65 years of age; the study learned decreased sepsis bundle
compliance occurred in the group over 65 years of age compared to the other group which
resulted in more negative patient outcomes. However, other studies report older individuals
diagnosed with sepsis had lower mortality rate when treated with all of elements of sepsis bundle
(El Solh, Akinnusi, Alsawalha & Pineda, 2008; Heppner et al., 2012; Nasa, Juneja & Singh,
2012). Although treating infection in adults older than 65 years is challenging, sepsis bundle
compliance is an evidence-based strategy to mitigate the higher risk of sepsis mortality in the
older population.
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Theoretical Model
For the purposes of this project, the Donabedian quality of care framework was used to
guide the scholarly project. Avedis Donabedian, a physician and professor of medical care
organization, was commissioned by the Health Services Research Section of the U.S Public
Health Service to evaluate research on quality assessment (Ayanian & Markel, 2016). From his
findings, he developed a framework to evaluate quality (Donabedian, 1966; Hickey & Brosnan,
2017).
The three concepts of the Donabedian model are structure, process, and outcomes
(Ayanian & Markel, 2016; Donabedian 1966; Hickey & Brosnan, 2017). This framework has
been used in multiple settings to evaluate quality such as implementation of nurse led triage, an
integrated trauma system, and providing care for pediatric patients in an ED (Abdelwahab, Yang,
& Teka 2017; Moore, Lavoie, Bourgeois, Lapointe, 2015; Ohns, Oliver-McNeil, Nantais-Smith,
& George, 2016). The important assumptions related to this model are that structure, processes,
and outcomes are all related and the relationships between all three concepts are unidirectional
(Donabedian, 1966). Figure 1 illustrates the organization of the specific scholarly project
elements into the Donabedian framework.
Structure
Structure refers to the administrative support needed for quality care and the environment
in which the health care occurs (Donabedian 1966; Hickey & Brosnan, 2017). The number of
available supplies and health care providers, and types of equipment are examples of structural
components (Donabedian 1966; Hickey & Brosnan, 2017). The structural components in the
scholarly project include the emergency department, the electronic health record (EHR) and the
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Sepsis Committee. The feature most important to the scholarly project was the retrieval of data
from the EHR.
Process
Process consists of provider and patient relationship and the ability of the provider to
develop therapeutic relationships with patients. The diagnostic tests, differential diagnoses,
interpretation of the results, and prescribed treatments are all process components (Donabedian
1966; Hickey & Brosnan, 2017). The current practices include the provider use of sepsis bundle,
the initial lactic acid level, and patients receiving the bundle elements. The data collection
facilitated understanding of current process and practices of an emergency department (ED). The
Sepsis Committee identified and shared barriers in the current process through an interview with
the scholarly project leader.
Outcomes
Outcomes are measurable change seen in health status because of the delivered health
care (Donabedian 1966; Hickey & Brosnan, 2017). Outcomes can be seen by both providers and
patients and are standard across all settings (Hickey & Brosnan, 2017). Outcomes such as
mortality and life expectancy reflect culture and values of family while specific disease
outcomes are a better indicator of provided health care quality (Hickey & Brosnan, 2017). The
mortality rate was the outcome measured in the scholarly project.
Application
The structure, process, and outcomes elements of the Donabedian quality of care
framework constructed the underpinning and support of this project. These three elements are
key factors in understanding this quality improvement project that assessed the association of the
three-hour sepsis bundle compliance and initial lactic acid level on mortality rate in adults
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diagnosed with sepsis in the ED. Donabedian (1966) reported that structure, process, and
outcomes provide unique information individually, but together facilitate an improved
understanding of the medical care process.
Project Design
The scholarly project used a retrospective chart review designed to evaluate the
association of three-hour sepsis bundle compliance and initial lactic acid level on mortality rate
in adults diagnosed with sepsis in the ED. The retrospective chart review obtained data about
patients diagnosed with severe sepsis and septic shock in an ED located in the southern region of
United States. The retrospective chart review captured data from January 1, 2016 to December
31, 2017. The scholarly project protocol, data collection, and design were approved by the
Belmont University Institutional Review Board. Additionally, through the collaboration, the
project was supported by the facility who granted access to the retrospective data.
Clinical Setting
Accessing the electronic health record (EHR) was accomplished at this facility. This
facility has 657 beds with 27 beds dedicated to the 24 hour adult emergency department. The
care of sepsis patients is a priority for this organization. The facility includes, Sepsis Committee,
which meets monthly to address issues related to sepsis care. This committee consists of chief
nursing officer (CNO), medical directors of ED and ICU, director of hospitalist service, sepsis
coordinator, nursing director, manager of ED, nurse manager of medical intensive care unit
(MICU), and a nurse from cardiovascular intensive care unit (CVICU). The committee reviews
sepsis cases by analyzing the successes and failures of each case, as well as continuously seeks
strategies to improve the process and outcome of caring for sepsis patients. This quality
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improvement project analyzed data, provided findings, and recommended interventions to the
committee that may help decrease sepsis mortality.
The facility’s mortality target goals in 2016 were to lower severe sepsis mortality by 10%
and lower septic shock mortality by 20%. The mortality target goals for 2017 for severe sepsis
were to lower sepsis mortality by 10% and to lower septic shock mortality by 30%. In relation to
sepsis diagnosis, providers, nurses, and paramedic technicians in the ED are aware of the
importance of early diagnosis and treatment of patients who might present with sepsis. The triage
process is crucial in alerting staff about possible sepsis patients.
When a patient arrives to the ED, a registered nurse (RN) or a paramedic triages the
patient. If a patient meets SIRS criteria for sepsis, a provider is notified. Immediately after the
patient is brought to an available room and a thorough history and physical obtained by the
provider and/or nurse, the sepsis order set is initiated that contains the three-hour sepsis bundle
elements. The RN completes the sepsis order set in a timely manner with the priority to obtain
initial lactic acid level, obtain two sets of blood culture from two different sites, administer
antibiotics after collecting two sets of blood cultures, and administering intravenous fluids. The
provider and the RN communicate about any abnormal changes throughout patient’s care in the
ED. Through the diagnostic testing, treatment, and evaluation of the patient’s overall response to
the treatment, the provider determines if the patient is admitted to the hospital for further
treatment or discharged home after ED treatment completion. Through the sepsis bundle
initiation, the patient receives standard of care and their mortality rate risk can be reduced. The
patient treatment and response data was captured from the EHR to analyze the processes and
outcomes of patients diagnosed with sepsis.
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Project Population
The project population consisted of cases identified through the retrospective chart
review of the EHR. A purposive sample was used through the use of ICD-10 and MS-DRG
codes. The inclusion criteria included patients age 18 and older, present on arrival (POA) with a
diagnosis of severe sepsis and septic shock in the ED, an ICD-10 diagnosis code R65.2 (severe
sepsis), R65.21 (septic shock) and MS-DRG code 871 (severe sepsis without mechanical
ventilation), and who met SIRS criteria during triage. The sample criteria were chosen because
the specific ED treats a high volume of sepsis patients aged 18 and older and the criteria match
the published evidence (Gaieski, Edwards, Kallan, & Carr, 2013; Seymour et al., 2017). Through
this project design and data collection, the project leader did not engage with patients directly.
Sources of Data
The retrospective chart review analyzed cases from January 1, 2016 through December
31, 2017. Data was retrieved from the facility EHR system applying the established inclusion
criteria. The independent variables are the three-hour sepsis bundle compliance and initial lactic
acid measurement. The data acquired included patient demographic characteristics: such as, age
and gender. Age was measured as a discrete ratio variable and gender measured as a
dichotomous variable. Ages 65 and greater were considered older individuals. The three-hour
sepsis bundle consists of four elements that included obtaining lactic acid level, obtaining blood
cultures prior to administration of antibiotics, administering broad spectrum antibiotics, and
administering intravenous fluids.
Lactic acid. When a patient meets SIRS criteria, lactic acid level is obtained. The normal
value for lactic acid ranges from 0-1.9 mmol/L. A lactic acid level 2.0 mmol/L or greater is
considered abnormal. In this project, the action of obtaining a lactic acid level was measured as a
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dichotomous variable and the actual numerical measurement of lactic acid level was measured as
a continuous ratio variable.
Blood cultures. Blood cultures were defined when one set of aerobic and one set of
anaerobic cultures were obtained. In this project, two sets of blood cultures received by the
laboratory prior to antibiotic administration were measured as a dichotomous variable.
Antibiotics. The administration of broad spectrum antibiotic therapy of one or more
drugs to have activity against all organisms is part of the three-hour sepsis bundle. In this project,
the administration of antibiotics was measured as a dichotomous variable.
Fluid therapy. The administration of 30ml/kg of crystalloid fluids in patients who
presented with hypotension or blood lactate concentration 4 mmol/L or greater was part of the
three-hour sepsis bundle. In this project, the administration of fluid therapy was considered a
dichotomous variable.
The dependent variable was mortality rate. Mortality was defined as a patient’s death in
the hospital. Mortality was measured as a dichotomous variable in this project. The Sepsis
Committee was also asked open ended questions concerning the barriers to sepsis bundle
implementation and ideas or changes that have been implemented to help decrease sepsis
mortality rates.
Data Collection Process
The data collection process started in August 2018 at the facility. Cases that met the
inclusion criteria were captured through the EHR and given to the project leader. The project
leader went to the facility twice a week to transcribe data using the facility’s computer in a
private office. The review of cases included ED providers’ notes, nurses’ notes, laboratory
results, medication orders and administration logs, case managements’ notes, hospitalists’ notes
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and discharge notes. Each case was searched by the medical record number (MRN) through the
EHR and results of each variable were transcribed on the Microsoft Excel sheet. The project
adhered to the regulations of the Health Insurance Portability and Protection Act (HIPPA) to
protect the confidentiality and anonymity of all cases. Each case was de-identified, assigned a
unique number, and recorded on the Excel sheet. Every 19th case, one case was chosen randomly
to double check results of the variables transcribed on the Excel sheet. If during the double
checking errors were found, every 5th case was randomly chosen to be double checked.
Statistical Analysis
Data was analyzed using IBM Statistical Package for Social Sciences (SPSS) 25.0 for
Windows. The demographic characteristics such as age and gender of the participants were
analyzed using descriptive statistics by using the mean and standard deviation. The first
hypothesis used Pearson chi-square test to compare mortality rates in individuals who did and
who did not receive three hour bundle elements. The second hypothesis used logistic regression
model to compare mortality rates and lactic acid levels. The third hypothesis used Pearson chi-
square test to compare mortality rates in older individuals who did and did not receive three hour
bundle elements. A p-value of 0.05 was employed with a 95% confidence interval.
Results
A total of 350 charts were collected through the retrospective chart review process. Nine
charts were not included because they failed to meet the SIRS criteria during triage process, one
of the inclusion criteria.
Sample Characteristics
A total sample of 341 charts was used for data analysis. Table 1 summarizes the age,
gender, and mortality rate characteristics. The individuals’ age ranged from 18 to 97 years old
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with an average age of 64.8 years (SD = 15.3) and a median age of 66 years. Forty seven percent
were female (n = 163) and 52.2% were male (n = 178). In 2016, the mortality rate was 25% (n =
124) and in 2017, the mortality rate was 14.3% (n = 217).
Overall Sepsis Bundle Compliance and Mortality
Of 341 charts, 340 charts were analyzed for the first hypothesis and one chart was
excluded due to missing data. Eighty one percent (n = 277) received three-hour bundle elements
compared to 18.5% (n = 63) who did not receive the three-hour bundle elements. A chi-square
test of independence (see Table 2) determined the relationships between individuals who
received and did not receive the three-hour bundle elements and mortality rates were statistically
significant ( χ2 = 3.93; p = 0.04). Individuals who received the three-hour bundle elements had
lower rates of mortality compared to individuals who did not receive the three-hour bundle
elements.
Lactic Acid and Mortality
Of 341 charts, 317 charts were analyzed for the second hypothesis and 24 charts were
excluded due to missing data. Lactic acid levels ranged from 0.3mmol/L to 18.0mmol/L with an
average lactic acid level of 3.8mmol/L (SD = 2.9) and a median level of 2.9mmol/L. A logistic
regression (see Table 3) was calculated to predict mortality rates based on lactic acid levels.
Higher lactic acid was associated with increased odds of mortality rates (adjusted odds ratio,
0.84; 95% confidence interval [CI], 0.77 to 0.92). Results indicated that the variables were
statistically significant (p < 0.01).
Older Individuals and Mortality
187 charts (N = 341) were individuals who were 65 years old and above. The mean age of
the sub-group was 76.0 (SD = 7.6) and median age was 75 years old. A chi-square test of
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independence (Table 4) determined the relationships between older individuals who received the
three-hour bundle and mortality rates were not statistically significant, ( χ2= 0.32, p = 0.56). No
statistically significant evidence was produced that older individuals who received all the three-
hour elements had lower mortality rates compared to those who did not receive all the three-hour
bundle elements.
Discussion
In this retrospective chart review, the Donabedian quality of care framework guided the
scholarly project through the concepts structure, process, and outcomes. The most important
structural feature of this study was the data collection obtained through EHR of individuals who
presented through the ED. The process and the outcomes components were studied through the
three hypotheses and their results.
Process and Outcomes
The use of sepsis bundle through the sepsis order set, the initial lactic acid level, patients
receiving the bundle elements, and the Sepsis Committee are the process components of this
project. The mortality rate was a measured outcome in all three hypotheses. The mortality rates
decreased by 10.7% from 2016 to 2017. The change in mortality rates could be attributed to staff
awareness about sepsis, educational programs by Sepsis Committee and possible updated
changes in the EHR.
The results confirm the first hypothesis. Individuals who received the three-hour bundle
elements did have lower rates of mortality compared to individuals who did not receive the
three-hour bundle elements. Previous research has shown the effectiveness of the three-hour
bundle compliance in increasing survival rates (Leisman et al., 2017; Lynn et al., 2018). The
results show that at this facility, the current process use of sepsis order set initiated the three-hour
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bundle elements to be carried out by staff which in turn facilitated lower mortality rates in the
ED. Further research can be useful in comparing provider’s use of sepsis order set with staff
driven sepsis protocols at other facilities.
The results for second hypothesis confirmed that individuals with higher initial lactic acid
level had higher rates of mortality compared to individuals who had decreased initial lactic acid
level. Gribben et al., (2016) conducted a study that showed that higher lactic acid in sepsis
patients did have higher mortality rates. Moreover, Filho et al., (2016) studied 443 patients with
severe sepsis and septic shock; patients with initial lactic acid levels greater than 2.5mmol/L had
a mortality rate more than 3.2 times higher than patients with lower or equal to 2.5mmol/L.
Further research can be useful in evaluating lactic acid level measurement as a sensitive marker
for sepsis patients.
The third hypothesis was not supported by the results. No relationship was demonstrated
between older individuals who received all the three-hour elements having lower mortality rates
compared to older individuals who did not. Prior research did report an association between
older adults and mortality rate when bundle compliant (El Solh, Akinnusi, Alsawalha & Pineda,
2008; Heppner et al., 2012; Nasa, Juneja & Singh, 2012). However, Rowe et al., (2016)
conducted a study which compared adults greater than 60 years old admitted to ICU with an
higher mortality when compared to those who did not receive all three-hour elements. This study
did not study the association of mortality with three-hour bundle compliance but suggested that
early use of antimicrobials and vasopressors may be associated with lowered in sepsis mortality
(Rowe et al., 2016). It can be challenging to identify sepsis in older adults because temperature,
heart rate, and white blood cell count may be diminished in older adults compared to younger
adults (Umberger, Callen & Brown, 2015). Since the current population contains a large
SEPSIS BUNDLE AND LACTIC
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proportion of older adults, early identification and prompt treatment is crucial in improving
mortality rates. Further research is warranted in evaluating different ways sepsis can be identified
in the older population.
The goal of the Sepsis Committee is to bring awareness to the hospital about sepsis,
improve the treatment of sepsis patients, and decrease sepsis mortality rates. The Sepsis
Committee identified the most important barrier of the current process in the ED and proposed an
idea that can be implemented to help with decreasing mortality rates through bundle compliance.
Most of the committee members agreed that a “check” box mentality can occur when the
provider orders the sepsis bundle, staff administers the ordered tests and treatment, but the
provider does not continue to monitor and treat the individual. An idea proposed by the project
leader and Sepsis Committee to overcome this barrier is to incorporate educational programs
every three months to increase provider and staff awareness of sepsis and to share results of
sepsis bundle compliance efforts.
This quality improvement project’s findings support that sepsis bundle compliance leads
to lower mortality rates. The project also supported that measurement of lactic acid is a vital part
of the bundle and helps providers gauge sepsis severity. To further improve outcomes, the
current processes can be improved. The project leader recommends education and training about
sepsis for the ED staff every three months and as needed. Online modules that include a pretest,
the clinical information, and a post test can be an effective approach. Sepsis reference pocket
cards given to staff and posters about the three-hour bundle can be placed in the department to
assist with staff awareness. Substantial evidence demonstrates the positive impact of sepsis
educational programs (Delaney et al., 2015; Ferrer et al., 2008; Herran-Monge et al., 2016).
SEPSIS BUNDLE AND LACTIC
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Implications for Practice
Since the initiation of the scholarly project started, there has been updates to the SSC
guidelines. The new SSC guidelines were revised with a major change to combine the three-hour
bundle and six-hour bundle into a single one-hour bundle (Levy, Evans, & Rhodes, 2018). This
major change communicates a sense of urgency to providers that resuscitation and management
of sepsis patients can be started immediately (Levy, Evans, & Rhodes, 2018). Early recognition
and prompt resuscitation are important especially in the ED, but also in other settings. This
should be addressed and studied in future projects to address the global burden of sepsis
mortality.
The findings from this project support the importance of three-hour sepsis bundle
compliance, initial lactic acid measurement and its relation to mortality rates. This scholarly
project confirms the importance of using evidence-based guidelines such as the three-hour
bundle to guide practice with sepsis patients. The project also highlights the value of the lactic
acid level for sepsis patients and aggressive treatment in the early hours. Continued
improvements in processes of care that enhance early recognition are necessary to further
improve outcomes of sepsis.
Strengths and Limitations
This project had limitations. Firstly, this was not a randomized trial, so results may be
biased by confounding factors. Secondly, although the data was from a single facility and, was
collected over two years from a large study population, the results may have limited external
validity. Thirdly, the project leader did not include any other variables in the logistic regression
model other than lactic acid levels. As research has shown, many factors influence mortality
rates (Rhee et al., 2019; Sanderson et al., 2018; Shen et al., 2012).
SEPSIS BUNDLE AND LACTIC
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Conclusion
The ED has a responsibility to provide the best overall care because it is the primary
gateway for many sepsis patients. While sepsis is recognized as hard to identify, the three-hour
bundle can improve sepsis mortality rates. The study did not find a relationship between older
individuals who received the three-hour elements and mortality rates. However, this project’s
results support that three-hour sepsis bundle compliance is associated with lowered mortality
rates and higher lactic acid level can assist in gauging risk of mortality.
SEPSIS BUNDLE AND LACTIC
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SEPSIS BUNDLE AND LACTIC
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Appendix
Figure 1 – Donabedian Quality of Care Framework. The red colored blocks are the specific
elements applied to the framework
SEPSIS BUNDLE AND LACTIC
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Table 1
Age, Gender, and Mortality Characteristics
Age in years (N = 341)
Mean (SD) 64.89 (15.34)
Median 66
Range 18 - 97
Gender (N = 341)
Female (%) 163 (47.8%)
Male (%) 178 (52.2%)
Mortality Rate in 2016 (n = 124)
Lived (%) 93 (75%)
Died (%) 31 (25%)
Mortality Rate in 2017 ( n = 217)
Lived (%) 186 (85.7%)
Died (%) 31 (14.3%)
Table 2
Chi Square Test for Overall Sepsis Bundle Compliance and Mortality
Overall Sepsis Bundle Compliance and Mortality
Compliance
Total N Y
Mortality D Count 6 56 62
L Count 57 221 278
Pearson Chi-Square
Value df p value
Pearson Chi-
Square
3.936a 1 0.047
Note. df = degrees of freedom a 0 cells have expected count less than 5. The minimum expected count is 11.49
Table 3
Logistic Regression for Lactic Acid and Mortality
B S.E. Wald df p Adjusted Odds Ratio 95% C.I.for EXP(B)
Lactic acid -0.17 0.04 14.63 1 <0.01 0.84 [0.77, 0.92]
SEPSIS BUNDLE AND LACTIC
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Note. CI = confidence interval df = degrees of freedom SE = standard error
Table 4
Chi Square test for Older Adults and Mortality
Mortality
Total D L
Compliance N 5 27 32
Y 31 124 155
Pearson Chi-square
Value df p
Pearson Chi-
Square
.327a 1 0.568
a 0 cells have expected count less than 5. The minimum expected count is 6.16