Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy - Full Text View

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 IV

Drug Information available for:

Sodium chloride Chlorides Sodium bicarbonate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Sodium Bicarbonate Versus Saline for the Prevention of Contrast-Induced Nephropathy in Patients Undergoing Coronary Angiography

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
A: Experimental 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
B: Active Comparator 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

Publications indexed to this study:

Maioli M, Toso A, Leoncini M, Gallopin M, Tedeschi D, Micheletti C, Bellandi F. Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. J Am Coll Cardiol. 2008 Aug 19;52(8):599-604.

Responsible Party:	Cardiology Unit ( Mauro Maioli MD )
Study ID Numbers:	Prato0701, POCARD0701
First Received:	January 22, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00606827
Health Authority:	Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:

Contrast-induced nephrophaty

Contrast media

Angiography

Coronary percutaneous intervention

Study placed in the following topic categories:

Urologic Diseases

Kidney Diseases

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Ospedale Misericordia e Dolce
Information provided by:	Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:	NCT00606827