drugset / Trial / NCT00606827

Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

NCT00606827 ↗

Phase 4 Completed 500 enrolled Ospedale Misericordia e Dolce
RandomizedParallel-groupDouble-blindPrevention

Summary

Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.

Timeline

Start
2005-01
Primary completion
—
Completion
2006-03

Outcome

Missed primary endpoint

paper Contrast-induced nephropathy occurred in 54 patients (10.8%); 25 (10%) were treated with sodium bicarbonate and 29 (11.5%) with saline (p = 0.60). PMID 18702961 ↗

paper Hydration with sodium bicarbonate plus NAC before contrast medium exposure is not more effective than hydration with isotonic saline plus NAC for prophylaxis of CIN PMID 18702961 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium bicarbonate Diagnostic / imaging agent 154 meq —
Comparator sodium chloride Unknown 0.9 % —

Indications

No indication recorded.