Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT00606827
First received: January 22, 2008
Last updated: May 6, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:

U.S. FDA Resources

Further study details as provided by 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ospedale Misericordia e Dolce

Additional 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
Study First Received: January 22, 2008
Last Updated: May 6, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Contrast-induced nephrophaty
Contrast media
Angiography
Coronary percutaneous intervention

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013