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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606827
First Posted: February 5, 2008
Last Update Posted: May 8, 2012
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.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
  Purpose
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 Intervention Phase
Contrast-Induced Nephropathy Drug: Sodium Bicarbonate Drug: Isotonic Saline Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mauro Maioli, Ospedale Misericordia e Dolce:

Enrollment: 500
Study Start Date: January 2005
Study Completion Date: March 2006
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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): NCT00606827


Locations
Italy
Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Investigators
Principal Investigator: Mauro Maioli, MD Cardiology Unit - Prato
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00606827     History of Changes
Other Study ID Numbers: Prato0701
POCARD0701
First Submitted: January 22, 2008
First Posted: February 5, 2008
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:
Kidney Diseases
Urologic Diseases


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