Mohammad G. Saklayen, MD, FACP
Does hydration controlled by the RenalGuard system prevent contrast-induced acute kidney injury (CI-AKI) in high-risk patients having angiography or angioplasty?
Randomized controlled trial (Renal Insufficiency After Contrast Media Administration Trial II [REMEDIAL II]). ClinicalTrials.gov NCT01098032.
Blinded (outcome adjudication committee).†
4 interventional cardiology centers in Italy.
294 patients (mean age 76 y, 65% men) who were scheduled for angiography or angioplasty, had chronic kidney disease, and had an estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 or a contrast neuropathy risk score ≥ 11 (based on hypotension, intra-aortic balloon pump support, heart failure, age > 75 y, diabetes mellitus, eGFR < 60 mL/min/1.73m2, preexisting anemia, and contrast agent volume). Exclusion criteria included dialysis; acute myocardial infarction or pulmonary edema; cardiogenic shock; multiple myeloma; use of iodinated contrast agent in the past 48 hours; and use of sodium bicarbonate, theophylline, dopamine, mannitol, or fenoldopam.
Intravenous (IV) N-acetylcysteine (NAC), 1500 mg in 1 L of saline, controlled by the RenalGuard system (PLC Medical Systems Inc., Franklin, Massachusetts, USA), which manages urine output and fluid balancing, plus IV furosemide, 0.25 mg/kg to a target urine flow of ≥ 300 mL/h, started before and continued until after the procedure (n = 147); or IV sodium bicarbonate, 154 mEq/L, started before and continued until after the procedure, plus IV NAC, 1200 mg in 100 mL of saline, given during the procedure, and oral NAC, 1200 mg, given twice daily on the day before and the day of contrast agent administration (n = 147).
CI-AKI (≥ 26.5 µmol/L [0.3 mg/dL] increase in serum creatinine level 48 h after contrast agent given or need for dialysis), acute renal failure needing dialysis, and major adverse events (death, renal failure needing dialysis, and acute pulmonary edema).
The main results are in the Table.
In high-risk patients, the RenalGuard system using saline plus N-acetylcysteine and furosemide was better than sodium bicarbonate plus N-acetylcysteine for preventing contrast-induced acute kidney injury.
‡CI-AKI = contrast-induced acute kidney injury; other abbreviations defined in Glossary. RRR, NNT, and CI calculated from odds ratios and control event rates (CI-AKI and in-hospital renal failure needing dialysis) or intervention and control event rates (major adverse events) in article.
§Death (4.1% vs 4.1%, P = 1.00); renal failure needing dialysis (0.7% vs 4.8%, P = 0.03); and acute pulmonary edema (2.1% vs 0.7%, P = 0.62).
Saklayen MG. The RenalGuard system reduced kidney injury more than a control system in high-risk patients. Ann Intern Med. 2012;156:JC1–9. doi: 10.7326/0003-4819-156-2-201201170-02009
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Published: Ann Intern Med. 2012;156(2):JC1-9.
Acute Kidney Injury, Nephrology.
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