Status:
COMPLETED
N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
Lead Sponsor:
University of Michigan
Conditions:
Transposition of Great Vessels
Congenital Heart Disease
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps preven...
Detailed Description
This is a randomized, placebo-controlled, blinded study of intravenous N-acetylcysteine (NAC) for the prevention of postoperative myocardial dysfunction and apoptosis in infants undergoing arterial sw...
Eligibility Criteria
Inclusion
- All patients transferred to or born at C.S. Mott Children's Hospital between 0 and 3-months-old undergoing ASO for d-TGA or anatomic variants (including double-outlet right ventricle with transposition physiology).
Exclusion
- Less than 36-weeks post-conceptional age at the time of enrollment
- Birth weight less than 1800 grams;
- Evidence of significant renal, hepatic, or neurological dysfunction
- Additional significant cardiac lesions other than patent ductus arteriosus, isolated ventricular septal defect, simple coarctation, and/or atrial septal defect
- Preoperative extracorporeal membrane oxygenation (ECMO).
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00374088
Start Date
February 1 2005
End Date
June 1 2008
Last Update
January 19 2012
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109-0204