Modified Perfusion for Neonatal Aortic Arch Reconstruction

Completed · Not applicable

Conditions studied: Aortic Arch Hypoplasia or Atresia

In brief

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.

Key facts

Study ID: NCT00490256
Run by: Emory University
People needed: 14
Starts: 2007-06-01
Expected to finish: 2010-06-01
Last updated by the study team: 2014-06-03

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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