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

January 27, 2009 updated by: Lenox Hill Hospital

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.

Study Overview

Status

Terminated

Conditions

Contrast Induced Nephropathy

Intervention / Treatment

Drug: sodium bicarbonate

Study Type

Interventional

Enrollment (Anticipated)

468

Phase

Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

serum creatinine greater then or equal to 1.5

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of contrast induced nephropathy Time Frame: 48-72 hours	48-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lenox Hill Hospital

Collaborators

GE Healthcare

Investigators

Principal Investigator: Jordan L Rosenstock, MD, Lenox Hill Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria