The Use of Sodium Bicarbonate in the Prevention of Contrast Induced Nephropathy - Tabular View

Tracking Information

First Received Date ^ICMJE

June 29, 2007

Last Updated Date

January 27, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of contrast induced nephropathy [ Time Frame: 48-72 hours ]

Change History

Complete list of historical versions of study NCT00494637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Contrast Induced Nephropathy

Intervention ^ICMJE

Drug: sodium bicarbonate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

468

Completion Date

January 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

serum creatinine greater then or equal to 1.5

Exclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00494637

Responsible Party

Jordan L. Rosenstock, MD, Lenox Hill Hospital

Study ID Numbers ^ICMJE

L06.10.058

Study Sponsor ^ICMJE

Lenox Hill Hospital

Collaborators ^ICMJE

GE Healthcare

Investigators ^ICMJE

Principal Investigator:

Jordan L Rosenstock, MD

Lenox Hill Hospital

Information Provided By

Lenox Hill Hospital

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP