Clinical Trials Directory

Trials / Completed

CompletedNCT00606827

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

Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
500 (actual)
Sponsor
Ospedale Misericordia e Dolce · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSodium BicarbonatePatients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
DRUGIsotonic SalinePatients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

Timeline

Start date
2005-01-01
Completion
2006-03-01
First posted
2008-02-05
Last updated
2012-05-08

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT00606827. Inclusion in this directory is not an endorsement.