Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Kidney Diseases Clinical Trial

Official title: A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

• NCT number: NCT00312117
• Study type: Interventional
• Source: Kaiser Permanente
• Status: Completed
• Phase: Phase 3
• Start date: January 2006
• Completion date: February 2006