Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II): RenalGuard System in high-risk patients for contrast-induced acute kidney injury.

Briguori C, Visconti G, Focaccio A, et al.
Circulation. 2011 Sep 13;124(11):1260-9. Epub 2011 Aug 15. (Original) PMID: 21844075


BACKGROUND: The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury.
METHODS AND RESULTS: The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate </=30 mL . min(-1) . 1.73 m(-2) and/or a risk score >/=11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of >/=0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate </=30 mL . min(-1) . 1.73 and 149 patients (51.5%) with only a risk score >/=11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate </=30 mL . min(-1) . 1.73 m(-2): odds ratio, 0.44; risk score >/=11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02+/-0.32 versus -0.08+/-0.26; P=0.002) and 48 hours (0.12+/-0.42 versus 0.03+/-0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group.
CONCLUSION: RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients. CLINICAL
TRIAL REGISTRATION(S): URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032.