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