Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study



Status:Enrolling by invitation
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 2
Updated:4/17/2018
Start Date:April 2016
End Date:January 2020

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Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity

Approximately 40,000 infants are born each year in the United States with congenital heart
defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the
United States. While advances in surgical treatment, cardiac bypass, and post-operative
management have improved mortality for children born with heart defects, these children
continue to have significant morbidity related to post-operative malnutrition, multiple organ
dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via
loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity.

The purpose of this multi-center observational cohort study is to understand the extent to
which practice variation for routine post-operative care might worsen intestinal barrier
dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical
correction of left sided cardiac obstructive defects. We will enroll 80 children with left
sided obstructive congenital cardiac lesions across several US congenital cardiac centers to
obtain clinical data and biological specimens. We will leverage existing differences in
nutritional and antibiotic strategies at these centers to better understand how intestinal
barrier function and the intestinal microbiome may contribute to post-operative multiple
organ dysfunction syndrome.


Inclusion Criteria:

- pre-operative diagnosis of left sided obstructive congenital cardiac defect

Exclusion Criteria:

- Corrected gestational age < 37 weeks at time of surgery

- Short bowel syndrome

- Intestinal graft vs. host disease

- Inflammatory Bowel Disease (Ulcerative Colitis, or Crohn's disease)

- Candidate for intestinal transplant

- History of necrotizing enterocolitis (NEC)

- Previous Randomization into this study
We found this trial at
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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