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Renal Insufficiency Following Contrast Media Administration Trial - REMEDIAL
Description:
The goal of the trial was to evaluate contrast volume supplementation with sodium bicarbonate or ascorbic acid in addition to N-acetylcysteine (NAC) in patients with chronic kidney disease undergoing invasive cardiac and/or peripheral procedures.
Study Design
Study Design:
Patients Screened: 393
Patients Enrolled: 326
Mean Patient Age: Mean age 70 years
Female: 17
Patient Populations:
Chronic kidney disease patients scheduled for coronary and/or peripheral angiography and/or angioplasty; and age ≥18 years; stable serum creatinine concentration ≥2.0 mg/dl and/or an estimated GFR <40 ml/min/1.73 m2
Exclusions:
Serum creatinine levels ≥8 mg/dl; a history of dialysis; multiple myeloma; pulmonary edema; acute myocardial infarction; recent exposure to radiographic contrast within 2 days of the study; pregnancy; or administration of theophylline, dopamine, mannitol, or fenoldopam
Primary Endpoints:
CIN, defined as an increase of ≥25% in the creatinine concentration 48 hours after the procedure
Drug/Procedures Used:
Patients with chronic kidney disease scheduled for coronary or peripheral procedures were randomized in a double-blind manner to saline infusion plus NAC (n = 111), sodium bicarbonate infusion plus NAC (n = 108), or 0.9% saline plus ascorbic acid plus NAC (n = 107). The iso-osmolar, nonionic contrast agent iodixanol was administered in all patients.
Principal Findings:
The procedure performed was percutaneous coronary intervention in 52% of patients, coronary angiography alone in 33% of patients, peripheral angiography in 6% of patients, and peripheral angioplasty in 8%. There was no difference in the amount of contrast media administered between the three groups (mean 179 ml for saline plus NAC, 169 ml for sodium bicarbonate plus NAC, and 169 ml for saline plus ascorbic acid plus NAC; p = 0.69).
The primary endpoint of contrast-induced nephrotoxicity (CIN) at 48 hours occurred less frequently in the bicarbonate plus NAC group (1.9%) than in the saline plus NAC group (9.9%, p = 0.019) or the saline plus ascorbic acid plus NAC group (10.3%) (p = 1.00 for saline plus NAC group vs. saline plus ascorbic acid plus NAC group). Likewise, a serum creatinine increase of ≥0.5 mg/dl occurred less frequently in the bicarbonate plus NAC group (0.9%) than in the saline plus NAC group (10.8%, p < 0.003) or the saline plus ascorbic acid plus NAC group (11.2%), as did a decrease in glomerular filtration rate (GFR) of ≥25% (0.9%, 9.2%, and 10.3%, respectively). Renal failure requiring temporary dialysis occurred in one patient in the saline plus NAC group (0.9%), one patient in the bicarbonate plus NAC group (0.9%), and four patients in the saline plus ascorbic acid plus NAC group (3.8%).
Interpretation:
Among patients with chronic kidney disease undergoing invasive cardiac and/or peripheral procedures with the iso-osmolar, nonionic contrast agent iodixanol, treatment with bicarbonate plus N-acetylcysteine was associated with a reduction in CIN compared with saline plus NAC or saline plus ascorbic acid plus NAC.
Despite the use of an iso-osmolar, nonionic contrast agent, approximately 10% of patients in the saline plus NAC or saline plus ascorbic acid plus NAC group developed CIN. This complication can lead to the need for temporary dialysis, which occurred in six patients in the trial.
References:
Briguori C, Airoldi F, D'Andrea D, et al. Renal Insufficiency Following Contrast Media Administration Trial (REMEDIAL). A Randomized Comparison of 3 Preventive Strategies. Circulation. 2007 Mar 13;115(10):1211-7.
Keywords: Triiodobenzoic Acids, Coronary Disease, Sodium Bicarbonate, Creatinine, Angioplasty, Percutaneous Coronary Intervention, Renal Dialysis, Bicarbonates, Coronary Angiography, Glomerular Filtration Rate, Renal Insufficiency, Chronic
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