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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Ochsner Health System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by:
Ochsner Health System
ClinicalTrials.gov Identifier:
NCT00939913
First received: July 14, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Nephropathy
Drug: intravenous NAC
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • Incidence of CIN [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • in-hospital mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • duration of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • serum cystatin C [ Time Frame: 48-72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939913

Contacts
Contact: Arthur Grant, MD (504) 842-6281 agrant@ochsner.org
Contact: Zehra Jaffery, MD 504-842-7157 zjaffery@ochsner.org

Locations
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Arthur G Grant, MD    504-842-6281    agrant@ochsner.org   
Principal Investigator: Arthur G Grant, MD         
Sponsors and Collaborators
Ochsner Health System
Cumberland Pharmaceuticals
  More Information

No publications provided by Ochsner Health System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arthur G. Grant MD, Ochsner medical center
ClinicalTrials.gov Identifier: NCT00939913     History of Changes
Other Study ID Numbers: IRB#2006.212.A
Study First Received: July 14, 2009
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ochsner Health System:
contrast nephropathy
intravenous n-acetlycysteine

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014