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REMEDIAL II

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.

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REMEDIAL II

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  1. 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.

  2. 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

  3. REMEDIAL II Secondary Endpoints • Increase in sCrconentration ≥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

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