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NCT01172353 Clinical Trial

Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

Renal Failure Clinical Trial

Official title:
Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01172353
Other study ID # HSaoLucas
Secondary ID
Status Completed
Phase Phase 3
First received July 28, 2010
Last updated January 7, 2014
Start date July 2004
Est. completion date February 2008

Study information
Verified date January 2014
Source Hospital Sao Lucas da PUCRS
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 301
Est. completion date February 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• sodium bicarbonate
hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
• saline
hydration with saline 1ml/Kg/h for 6 hours

Locations
Country Name City State
Brazil São Lucas Hospital - PUCRS University Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Lucas da PUCRS

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Contrast-induced Nephropathy rise in serum creatinine >0,5mg/dl 48 hours No
Secondary Dialysis During Hospitalization During hospitalization No
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