Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier:
NCT01172353
First received: July 28, 2010
Last updated: January 7, 2014
Last verified: January 2014
  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:


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 [ Time Frame: During hospitalization ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Osorio Gomes, MD, PhD, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier: NCT01172353     History of Changes
Other Study ID Numbers: HSaoLucas
Study First Received: July 28, 2010
Results First Received: January 7, 2014
Last Updated: January 7, 2014
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 July 28, 2014