Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy (NAC)

September 17, 2009 updated by: Ochsner Health System

N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes

In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from < 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC.

This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com).

Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
        • Contact:
        • Principal Investigator:
          • Arthur G Grant, MD

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older.
  2. Hospitalized with a primary diagnosis of acute coronary syndrome.
  3. Scheduled for coronary angiography or intervention during the current hospitalization.

Exclusion Criteria:

  1. Have end-stage renal disease (ESRD) requiring dialysis.
  2. Have a known hypersensitivity to NAC.
  3. Have a history of life-threatening contrast reaction. -

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: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: intravenous N-acetlycysteine

intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)as compared to placebo

Acetadote provided by Cumberland Pharmaceuticals Inc.
Drug: intravenous NAC
intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours)
Placebo Comparator: Placebo
Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.
Drug: Placebo
Study participants will be randomized to receive an intravenous regimen of NAC (1,200 mg bolus followed by 200 mg/hour for 24 hours) or placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of CIN
Time Frame: 48-72 hours
48-72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
30 day mortality
Time Frame: 30 days
30 days
duration of hospitalization
Time Frame: 30 days
30 days
in-hospital mortality
Time Frame: 30 days
30 days
serum cystatin C
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

Ochsner Health System

Collaborators

Cumberland Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2007

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#2006.212.A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe