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Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01172353
Recruitment Status : Completed
First Posted : July 29, 2010
Results First Posted : February 19, 2014
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: sodium bicarbonate Drug: saline Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
Study Start Date : July 2004
Primary Completion Date : January 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Contrast-induced Nephropathy [ Time Frame: 48 hours ]
    rise in serum creatinine >0,5mg/dl


Secondary Outcome Measures :
  1. Dialysis During Hospitalization [ Time Frame: During hospitalization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172353


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

Responsible Party: Vitor Osorio Gomes, MD, PhD, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier: NCT01172353     History of Changes
Other Study ID Numbers: HSaoLucas
First Posted: July 29, 2010    Key Record Dates
Results First Posted: February 19, 2014
Last Update Posted: February 19, 2014
Last Verified: January 2014

Keywords provided by Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS:
contras-induced nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Urologic Diseases