Prevention of contrast induced nephropathy with sodium bicarbonate (the PROMEC study)

• Published in: Brazilian Journal of Nephrology Vol. 36; no. 3; pp. 360 - 366
• Main Authors: Nieto-Ríos, John Fredy, Salazar, Wílmar Arley Maya, Sánchez, Oscar Mauricio Santos, Ortega, Janeth Liliana Jaramillo, Caro, Jorge Ignacio García, Aristizabal, Julián Miguel Aristizabal, Higuita, Lina Maria Serna, García, Álvaro García, Barragán, Fabián Alberto Jaimes
• Format: Journal Article
• Language: English
• Published: Brazil Sociedade Brasileira de Nefrologia 01-07-2014
• Subjects: Adult; Aged; Aged, 80 and over; bicarbonato de sódio; Contrast Media - adverse effects; Female; Humans; Kidney Diseases - chemically induced; Kidney Diseases - prevention & control; lesão renal aguda; Male; meios de contraste; Middle Aged; Prospective Studies; Single-Blind Method; Sodium Bicarbonate - therapeutic use; solução salina; Young Adult
• ISSN: 0101-2800; 2175-8239; 2175-8239
• DOI: 10.5935/0101-2800.20140051

Contrast-induced nephropathy is a common complication of radiographic procedures. Different measures have been used to avoid this damage, but the evidence is controversial. New investigations are required to clarify it. We investigated the efficacy and safety of sodium bicarbonate solution compared with sodium chloride solution to prevent contrast induced nephropathy in patients with or at risk of renal dysfunction.
A prospective, single-center, randomized clinical trial conducted from May 1, 2007 to February 8, 2008. Inpatients in a tertiary center, scheduled to undergo a procedure with the nonionic radiographic contrast agent iohexol. There were 220 patients with serum creatinine levels of at least 1.2 mg/dL (106.1 µmol/L) and/or type 2 diabetics, who were randomized to receive an infusion of sodium chloride (n = 113) or sodium bicarbonate (n = 107) before and after contrast dye administration. The intervention were "A" group received 1 ml/kg/hour of normal saline solution, starting 12 hours before and continuing 12 hours after iohexol contrast. "B" group received 3 ml/kg of sodium bicarbonate solution (150 mEq/L) one hour prior to procedure and then drip rate was decreased to 1 ml/kg/hour until 6 hours post procedure. Our main outcome measure was change in serum creatinine.
The mean creatinine value after the procedure was 1.26 mg/dL in the saline group and 1.22 mg/dL in the bicarbonate group (mean difference: 0.036; CI 95%: -0.16 to 0.23, p = 0.865). The diagnosis of contrast-induced nephropathy, defined by increase in serum creatinine on 25% or more within 2 days after administration of radiographic contrast, was done in twelve patients (12%) in the bicarbonate group and eighth patients (7.1%) in the saline group (RR: 1.68, CI 95%: 0.72 to 3.94).
Our investigation showed that there were no differences between normal saline solution (extended infusion) vs. bicarbonate solution for nephroprotection.