Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Phase 3

Completed

• Conditions: Renal Failure
• Interventions: Drug: saline; Drug: sodium bicarbonate

• Registration Number: NCT01172353
• Lead Sponsor: Hospital Sao Lucas da PUCRS

Brief Summary

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Status Verified: 2014-01
• Results First Submitted: 2014-01-07
• Results First Submitted QC: 2014-01-07
• Last Update Submitted: 2014-01-07
• Results First Posted: 2014-02-19
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• serum creatinine > 1.1 mg/dL
• glomerular filtration rate (GFR) < 50 mL/min

Exclusion Criteria

• age < 18 years
• use of radiographic contrast media during the last 21 days
• history of dialysis
• cardiac insufficiency class III-IV
• emergency procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	saline	hydration with saline 1ml/Kg/h for 6 hours
sodium bicarbonate	sodium bicarbonate	hydration with sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
Contrast-induced Nephropathy	48 hours	rise in serum creatinine \>0,5mg/dl

Secondary Outcome Measures

Name	Time	Method
Dialysis During Hospitalization	During hospitalization

Trial Locations

Locations (1)

São Lucas Hospital - PUCRS University; 🇧🇷 Porto Alegre, RS, Brazil