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

This study has been completed.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce Identifier:
First received: January 22, 2008
Last updated: May 6, 2012
Last verified: May 2012
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 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:

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
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
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00606827

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce Identifier: NCT00606827     History of Changes
Other Study ID Numbers: Prato0701
Study First Received: January 22, 2008
Last Updated: May 6, 2012

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

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017