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

Phase 4

Completed

• Conditions: Contrast-Induced Nephropathy
• Interventions: Drug: Isotonic Saline; Drug: Sodium Bicarbonate

• Registration Number: NCT00606827
• Lead Sponsor: Ospedale Misericordia e Dolce

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study Completion: 2006-03
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Isotonic Saline	Saline
A	Sodium Bicarbonate	Bicarbonate

Trial Locations

Locations (1)

Ospedale Misericordia e Dolce; 🇮🇹 Prato, Italy