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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Our investigation showed that there were no differences between normal saline solution (extended infusion) vs. bicarbonate solution for nephroprotection.

Prevention of contrast induced nephropathy with sodium bicarbonate (the PROMEC study) / Prevenção de nefropatia por contraste com bicarbonato de sódio (o estudo PROMEC)

Introduction: 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. Methods: 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. Results: 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). Conclusion: Our investigation showed that there were no differences between normal saline solution (extended infusion) vs. bicarbonate solution ...

Introdução: A nefropatia induzida por contraste é uma complicação comum de procedimentos radiográficos. Medidas diferentes têm sido utilizadas para evitar estes problemas, mas a evidência é controversa. Novos estudos são necessários para esclarecer isso. Investigamos tanto a eficácia quanto a segurança de uma solução de bicarbonato de sódio em comparação com a solução de cloreto de sódio para evitar nefropatia por contraste em pacientes com ou em risco de desenvolver disfunção renal. Métodos: Estudo prospectivo, randomizado clínico, conduzido em um único centro, entre 01 de maio de 2007 e 8 de fevereiro de 2008. Os pacientes internados em um centro terciário, agendados para passar por um procedimento radiográfico com uso de contraste não iônico., Havia 220 pacientes com níveis de creatinina sérica de pelo menos 1,2 mg/dL (106,1 mmol/L) e/ou diabéticos do tipo 2, que foram escolhidos aleatoriamente para receber uma infusão de cloreto de sódio (n = 113) ou bicarbonato de sódio (n = 107) antes e após a administração do meio de contraste. A intervenção foi: grupo "A" recebeu 1 ml/kg/hora de solução salina normal, começando 12 horas antes e continuando por 12 horas após o uso do contraste iohexol. Os pacientes do grupo "B" receberam 3 ml/kg de uma solução de bicarbonato de sódio (150 mEq/L), 1 hora antes do procedimento e, em seguida, o gotejamento foi reduzido a 1 ml/kg/hora por até 6 horas após o procedimento. Nosso principal indicador de desfecho foi a alteração na creatinina sérica. Resultados: O valor médio da creatinina após o procedimento foi de 1,26 mg/dL no grupo que recebeu a solução salina e 1,22 mg/dL no grupo do bicarbonato (diferença média: ...