Phase 2
N=21
N-Acetylcysteine in Neonatal Congenital Heart Surgery (INACT Study)
Transposition of Great Vessels · Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00374088 ↗Enrolled (actual)
21
Serious AEs
14.3%
Results posted
Jan 2012
Primary outcome: Primary: Maximum Decline in Measured Cardiac Output — 0.68; 0.29 L/min/m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Decline in Measured Cardiac Output |
0.68; 0.29 | — |
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 prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT00374088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.