N/A
N=14
Modified Perfusion for Neonatal Aortic Arch Reconstruction
Aortic Arch Hypoplasia or Atresia
Bottom Line
View on ClinicalTrials.gov: NCT00490256 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Intestinal Fatty Acid Binding Protein and C-reactive Protein
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Modified Selective Cerebral Perfusion (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intestinal Fatty Acid Binding Protein and C-reactive Protein |
— | — |
| PRIMARY iFAB Post-op |
1590; 564 | — |
| SECONDARY Cerebral and Lower Body Near Infra-red Spectroscopy Measures |
— | — |
Summary
Even though the lower part of the body does receive some blood supply during Cardiopulmonary Bypass(CPB) surgery, it may not be enough. As a result of this lowered blood supply, there are complications associated with CPB and clamping of the aorta. These include complications with the stomach, intestines and kidneys.
The hypotheses of this study are that increased lower body perfusion during aortic arch reconstruction will decrease intestinal ischemia and the incidence of necrotizing enterocolitis, improve renal function in the postoperative period, and shorten both intensive care unit and hospital length of stay.
The purpose of this research study is to provide the lower part of the body and its organs with possibly more blood supply with a modified form of cardiopulmonary bypass and see if this additional blood supply helps to decrease complications of the kidney, stomach and intestines.
Eligibility Criteria
Inclusion Criteria
- Diagnosis including aortic coarctation, arch hypoplasia, or interrupted aortic arch which requires cardiopulmonary bypass for repair
- age less than 1 year
- parental consent for participation
Exclusion Criteria
- prior aortic arch operations
- emergency operation
- operating surgeon decides that selective cerebral perfusion is not indicated
- Documented renal insufficiency (creatinine > 2.0) or evidence of bowel ischemia prior to surgery
Data sourced from ClinicalTrials.gov (NCT00490256). 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.