Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL)

Abstract

Background-Volume supplementation by saline infusion combined with N-acetylcysteine (NAC) represents an effective strategy to prevent contrast agent-induced nephrotoxicity (CIN). Preliminary data support the concept that sodium bicarbonate and ascorbic acid also may be effective in preventing CIN. Methods and Results-Three hundred twenty-six consecutive patients with chronic kidney disease, referred to our institutions for coronary and/or peripheral procedures, were randomly assigned to prophylactic administration of 0.9% saline infusion plus NAC (nϭ111), sodium bicarbonate infusion plus NAC (nϭ108), and 0.9% saline plus ascorbic acid plus NAC (nϭ107). All enrolled patients had serum creatinine Ն2.0 mg/dL and/or estimated glomerular filtration rate Ͻ40 mL · min Ϫ1 · 1.73 m

Excessively High Hydration Volume May Not Be Associated With Decreased Risk of Contrast‐Induced Acute Kidney Injury After Percutaneous Coronary Intervention in Patients With Renal Insufficiency

“…The most frequently used protocol for hydration with saline to prevent CI‐AKI in patients with chronic kidney disease in controlled trials involves fluid supplementation for 12 hours before and after the procedure, rather than 24 hours before and after the procedure, at a speed of 1 mL/kg per hour. In these patients, the CI‐AKI incidence has been reported to be ≈10%, which is similar to that observed in the present study using the same protocol 12, 19, 20, 21, 22. However, more than three quarters of the patients in our real‐world study received a lower hydration volume (<17 mL/kg) than that administered in the above‐mentioned studies.…”

Incidence and Outcomes of Contrast-Induced AKI Following Computed Tomography

“…However, only 2 patients (0.5%) in our study met criteria for the RISK stage of kidney injury using the RIFLE criteria, and none manifested more advanced kidney injury. This suggests that the use of small changes in Scr to estimate sample size requirements, although helping to ensure a sufficient number of primary study "events," likely results in inadequate power to assess clinically meaningful outcomes (23)(24)(25)(26)(27)(28). We conducted post hoc analyses to determine the sample size requirements of a clinical trial testing a hypothetical intervention that would reduce the incidence of CIAKI, from 3.5%, which was the incidence in our study using a definition of an increase in Scr Ն0.5 mg/dl, to 1.75%.…”

Hidratação com bicarbonato de sódio não previne a nefropatia de contraste: ensaio clínico multicêntrico

“…Posterior studies evaluated sodium bicarbonate in the prevention of CIN in patients submitted to the angiography and/or PCI produced conflicting results [17][18][19][20][21][22][23] . Some of these studies evaluated the use of sodium bicarbonate plus N-acetylcysteine 17,19,21,23 and, therefore, do not allow for a definitive conclusion regarding the benefit of isolated sodium bicarbonate in CIN prophylaxis, once the evaluation of two drugs simultaneously is an important confusion bias.…”

“…Some of these studies evaluated the use of sodium bicarbonate plus N-acetylcysteine 17,19,21,23 and, therefore, do not allow for a definitive conclusion regarding the benefit of isolated sodium bicarbonate in CIN prophylaxis, once the evaluation of two drugs simultaneously is an important confusion bias. Among studies that compared only sodium bicarbonate and saline solution, the results are also inconsistent 18,20,22 .…”

“…However, there is limited and controversial data regarding assessing the efficacy of sodium bicarbonate in patients undergoing cardiac catheterization [17][18][19][20][21][22][23] .…”