Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy

Nephropathy Clinical Trial

— NAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00939913
• Other study ID #: IRB#2006.212.A
• Status: Recruiting
• Phase: Phase 4
• First received: July 14, 2009
• Last updated: September 17, 2009
• Start date: January 2007
• Est. completion date: May 2010

Study information

• Verified date: September 2009
• Source: Ochsner Health System
• Contact: Arthur Grant, MD
• Phone: (504) 842-6281
• Email: agrant[@]ochsner.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Nephropathy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Ochsner Health System	Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CIN		48-72 hours	No
Secondary	in-hospital mortality		30 days	Yes
Secondary	30 day mortality		30 days	Yes
Secondary	duration of hospitalization		30 days	Yes
Secondary	serum cystatin C		48-72 hours	No