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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Contrast-induced Nephropathy

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Misericordia e Dolce

Prato, 59100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients with creatinine clearance < 60 mL/min

Exclusion criteria

contrast medium administration within the previous 10 days
end-stage renal failure requiring dialysis
refusal to give informed consent

Treatment and study plan

Sodium bicarbonate

Drug

Patients 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

Isotonic saline

Drug

Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

Sponsors and collaborators

Lead sponsor

Ospedale Misericordia e Dolce

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2006
First posted: Feb 5, 2008
Registry last updated: May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed