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OpenTrials
Completed

NCT Number: NCT02824705

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Congenital Heart Disease Surgery

Procedure

Stool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention.

Primary outcomes

  1. Change from baseline intestinal epithelial barrier biomarker profile

    Time frame: 04/2016-01/31/2020

  2. Microbiome diversity

    Time frame: 04/2016-01/31/2020

Secondary outcomes

  1. Multiple Organ Dysfunction Syndrome

    Time frame: 04/2016-01/31/2020

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2016
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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