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Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier:
NCT01172353
First received: July 28, 2010
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Renal Failure
 Drug: sodium bicarbonate
Drug: saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Sao Lucas da PUCRS:

Primary Outcome Measures:
  • contrast-induced nephropathy [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    rise in serum creatinine >0,5mg/dl


Secondary Outcome Measures:
  • dialysis during hospitalization [ Designated as safety issue: No ]
  • length of hospitalization [ Designated as safety issue: No ]
  • in-hospital mortality [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: July 2004
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium bicarbonate
hydration with sodium bicarbonate
 Drug: sodium bicarbonate
hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
Active Comparator: saline
hydration with saline 1ml/Kg/h for 6 hours
 Drug: saline
hydration with saline 1ml/Kg/h for 6 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172353

Locations
Brazil
São Lucas Hospital - PUCRS University
Porto Alegre, RS, Brazil, 90610-000
Sponsors and Collaborators
Hospital Sao Lucas da PUCRS
  More Information

No publications provided

Responsible Party: Vitor Osório Gomes / Medical doctor, PhD
ClinicalTrials.gov Identifier: NCT01172353     History of Changes
Other Study ID Numbers: HSaoLucas
Study First Received: July 28, 2010
Last Updated: July 28, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sao Lucas da PUCRS:
contras-induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013