Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged
hospitalization, significant morbidity/mortality, and cost. In addition, these patients may
require temporary or permanent hemodialysis which, in turn, is associated with further
morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired
renal failure. In recent years, studies have investigated preventive therapies with mixed
results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has
been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be
beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical.
Mucomyst has shown mixed results. The single strategy which most would agree as being
beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most
recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial
(n=119). It is clear that the most cost effective strategies for treatment of CN should be
aimed at prevention.
The general question is: "Is a sodium bicarbonate solution more efficacious in preventing
contrast nephropathy compared to normal saline?" The general hypothesis is that sodium
bicarbonate will be more efficacious.