Recruiting

Acetadote

Sponsor:

Ochsner Health System

Code:

NCT00939913

Conditions

Nephropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

intravenous NAC

Placebo

Study Details

Brief summary:

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.

Conditions

Nephropathy

Study ID

NCT00939913

Start date

Jan, 2007

Status verified date

Sep, 2009

Completion date

May, 2010

Anticipated

Primary completion date

May, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

intravenous NAC

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

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.

Primary outcome measure

  • Incidence of CIN [ Time Frame: 48-72 hours ]

Central Contacts and Locations

Central contacts

Arthur Grant, MD

(504) 842-6281agrant@ochsner.org

Zehra Jaffery, MD

504-842-7157zjaffery@ochsner.org

Locations

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Arthur G Grant, MD

504-842-6281agrant@ochsner.org

Principal Investigator:

Arthur G Grant, MD

More Information

Sponsor

Ochsner Health System

Last update posted

Sep 18, 2009

Last verified

Sep, 2009

Keywords

  • contrast nephropathy
  • intravenous n-acetlycysteine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2009-09-18.