the redoxs © study reducing deaths from oxidative stress part 3 of 3 sponsor dr. daren heyland, md,...
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The REDOXS© Study REducing Deaths due to OXidative Stress
The REDOXS© StudyREducing Deaths from OXidative Stress
Part 3 of 3Sponsor
Dr. Daren Heyland, MD, FRCPC
Project LeaderRupinder Dhaliwal, BASc, RD
Pharmacy
Pharmacy Log In
Check if you need to configure web browser BEFORE your enrol !
Pharm Manual p 5
Passwords assigned once regulatory approvals in place
Pharmacy Treatment assignment
Note: this is not the randomization list that will be used for the study.
Pharm Manual p 6
Supply of Supplements
• Fresenius Kabi
• Selenium from Pharmacy (TBD)
• Before start: Supplies to be shipped to sites
• Need updated pharmacy contact and shipping address
Dispensing
• ICU pharmacist dispensing pharmacist
• Sign signature log
• Enteral supplements– no mixing needed
• Parenteral supplements– Mixing required: Dipeptiven (Glutamine) +
Selenium (AOX) + Normal Saline
If hypernatremia, can be mixed in with D5W instead of saline!
Pharm Manual p 12
Enteral Products
• Obtain appropriate enteral product • Infuse at 20 ml/hour for all patients• Generate pharmacy label (need 2 labels)
Pharm Manual p 12, 29
Remove company label and staple to Form B
Attach pharmacy label to bottle
(maintain blinding)
Pharm Manual p 12, 13
Enteral Dispensing LogPharm Manual p 14
Mixing of Parenteral SupplementsDipeptiven (Glutamine) + Selenium (AOX) + Normal Saline
Final volume = 250 mls, hourly rate = 10 ml/hr.
1. Determine dose of Glutamine according to Normal weight
• Normal Weight (kg) = height (cms) –100 cms
• Dose of Dipeptiven = Normal wt. X 2.5 mls
(This equals to Normal wt. X 0.35 gms of Glutamine or Normal weight X 0.5 gms of L-alanyl-L-Glutamine).
2. Dose of Selenium = 12.5 ml (500 micrograms) = 1.25 vial
EU sites: dose is 10 mls (500 micrograms
3. Combine the Glutamine + Selenium and remove this volume from 250 ml of normal saline.
4. Replace normal saline with this mixture. Final volume =250 mls.
Pharm Manual p 15
Parenteral Worksheet: AOX
Pharm Manual p 15, 31-34
Refer to Revised
Worksheets November 2007
Parenteral Worksheet: GLN
Parenteral Worksheet: AOX+GLN
Dosages according to height (PN)If > 6 feet 5 inches (>196 cms)
•Final volume of parenteral solution will be between 250-300 mls.
•Can still use 250 mls bag of saline
•If no normal saline to be used, use an empty sterile bag and add supplements to the bag (instead of removing all normal saline)
•Final rate of solution will exceed 10 ml/hr
•Central line needed but peripheral may be used (72 hrs max)
Pilot Study: no one > 190 cms (6’3”)
Pharm Manual p 18, 36
Refer to Revised
Worksheets November 2007
Expiration of Supplements
• Selenium once opened: 24 hrs if refrigerated• Dipeptiven once opened: mix immediately
• Once mixed, parenteral solutions have an expiration of 96 hrs room temperature– Can make in batches to last 3 days!!
Enteral Supplements once opened: 24 hrs
Pharm Manual p 10
Parenteral Study Supplement Log
Pharm Manual p 17
Parenteral Label
Pharm Manual p 16, 35
Nutrient Accountability LogsOne log for each product except
for normal saline
Pharm Manual p 19-25
Monthly Site Inventory Log
Fax in to CERU monthly
Pharm Manual p 8,9
Temperature Log
Fax in to CERU monthly
Pharm Manual p 10, 11
Case Study: Dosing errorREDOXS Pharmacist away for weekend and returns on
Monday and after reviewing logs realizes that Mr. J.S accidentally received the wrong supplements. Should have received GLN but received GLN+AOX instead for the last 18 hours.
What to do? 1. Stop the infusion immediately
2. Inform research coordinator ASAP, maintain blinding
3. Notify CERU immediately, Note to File
4. Steps to prevent recurrence
FAQs Pharmacy
• Keep vials of returned/destroyed products?
• One password for all Pharmacists/technicians?
• Pharmacist or technician that dispenses the supplements?
P. Manual page 16
REDOXS© Circular and Bulletin
Questions?? Imp Manual Tools