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Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy

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ClinicalTrials.gov Identifier: NCT00606827
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce

Study Description
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Brief Summary:
Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.

Condition or disease Intervention/treatment Phase
Contrast-Induced Nephropathy Drug: Sodium Bicarbonate Drug: Isotonic Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sodium Bicarbonate Versus Saline for the Prevention of Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography
Study Start Date : January 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Bicarbonate
 Drug: Sodium Bicarbonate
Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure
Active Comparator: B
Saline
 Drug: Isotonic Saline
Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with creatinine clearance < 60 mL/min

Exclusion Criteria:

  • contrast medium administration within the previous 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606827


Locations
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Italy
Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Investigators
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Principal Investigator: Mauro Maioli, MD Cardiology Unit - Prato
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00606827    
Other Study ID Numbers: Prato0701
POCARD0701
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by Mauro Maioli, Ospedale Misericordia e Dolce:
Contrast-induced nephrophaty
Contrast media
Angiography
Coronary percutaneous intervention
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases