RESUMO
In this study, we investigated whether hydration with sodium bicarbonate is superior to hydration with saline in addition to theophylline (both groups) in the prophylaxis of contrast-induced nephropathy (CIN). It was a prospective, randomized, double-blinded study in a university hospital on 2 general intensive care units (63% of investigations) and normal wards.After approval of the local ethics committee and informed consent 152 patients with screening serum creatinine ≥1.1âmg/dL and/or at least 1 additional risk factor for CIN undergoing intravascular contrast media (CM) exposure were randomized to receive a total of 9âmL/kg bicarbonate 154âmmol/L (group B; nâ=â74) or saline 0.9% (group S; nâ=â78) hydration within 7âh in addition to intravenous application of 200âmg theophylline. Serum creatinine was determined immediately before, 24 and 48âh after CM exposure. As primary endpoint we investigated the incidence of CIN (increase of serum creatinine ≥0.5âmg/dL and/or ≥25% within 48âh of CM).Both groups were comparable regarding baseline characteristics. Incidence of CIN was significantly less frequent with bicarbonate compared to sodium hydration (1/74 [1.4%] vs 7/78 [9.0%]; Pâ=â0.035). Time course of serum creatinine was more favorable in group B with decreases in serum creatinine after 24âh (-0.084âmg/dL [95% confidence interval: -0.035 to -0.133âmg/dL]; Pâ=â0.008) and 48âh (-0.093âmg/dL (-0.025 to -0.161âmg/dL); Pâ=â0.007) compared to baseline which were not observed in group S.In patients at increased risk of CIN receiving prophylactic theophylline, hydration with sodium bicarbonate reduces contrast-induced renal impairment compared to hydration with saline.