remedial ii
DESCRIPTION
REMEDIAL II. Renal Insufficiency Following Contrast Media Administration Trial II (REMEDIAL II): RenalGuard ™ System In High-Risk Patients for Contrast-Induced Acute Kidney Injury. Hypothesis. - PowerPoint PPT PresentationTRANSCRIPT
REMEDIAL II
Renal Insufficiency Following Contrast Media Administration Trial II
(REMEDIAL II): RenalGuard™ System In High-Risk Patients for Contrast-
Induced Acute Kidney Injury
Hypothesis
The RenalGuard™ System is superior to prophylaxis with sodium bicarbonate infusion plus
NAC in preventing CI-AKI in high and very high risk patients.
The RenalGuard™ System
A real-time measurement and real-time matched fluid replacement device designed to
accommodate RenalGuard™ therapy
RenalGuard™ Therapy
The theory that creating and maintaining a high urine output is beneficial by allowing a quick
elimination of contrast media, thereby reducing its toxic effects.
REMEDIAL II
Study Design
Randomized, multicenter, investigator-sponsored
Primary Endpoint
• The rate of contrast induced acute kidney injury (CI-
AKI), defined as an increase of ≥0.3 mg/dL in serum
creatinine (sCr) concentration 48 hours after the
procedure
Secondary Endpoints
• Increase in sCr conentration ≥25% and ≥0.5 mg/dL at
48 hours post contrast exposure
• Changes in serum cystatin concentration at 24 and 48
hours post contrast exposure
• Rate of acute renal failure requiring dialysis
• Rate of in-hospital and 1-month major adverse events
REMEDIAL II