The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy

This study has been terminated.

( Not reaching recruitment and endpoint goals )

First Received on June 29, 2007. Last Updated on January 27, 2009 History of Changes

Sponsor:	Lenox Hill Hospital
Collaborator:	GE Healthcare
Information provided by:	Lenox Hill Hospital
ClinicalTrials.gov Identifier:	NCT00494637

Purpose

Preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. The investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. The primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. Patients with an ejection fraction <30%, overt CHF, hypokalemia and alkalemia will be excluded.

Condition	Intervention
Contrast Induced Nephropathy	Drug: sodium bicarbonate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by Lenox Hill Hospital:

Primary Outcome Measures:

Incidence of contrast induced nephropathy [ Time Frame: 48-72 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	468
Study Start Date:	July 2007
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

isotonic sodium bicarbonate at 3 cc/kg for one hour followed by 2 cc kg/hr for 4 hours

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

serum creatinine greater then or equal to 1.5

Exclusion Criteria:

EF<30
Overt CHF
Alkalemia
Hypokalemia
GFR<20 cc/min

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494637

Sponsors and Collaborators

Lenox Hill Hospital

GE Healthcare

Investigators

Principal Investigator:

Jordan L Rosenstock, MD

Lenox Hill Hospital

More Information

No publications provided

Responsible Party:	Jordan L. Rosenstock, MD, Lenox Hill Hospital
ClinicalTrials.gov Identifier:	NCT00494637 History of Changes
Other Study ID Numbers:	L06.10.058
Study First Received:	June 29, 2007
Last Updated:	January 27, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012