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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02824705
Enrollment
53
Registered
2016-07-07
Start date
2016-04-30
Completion date
2021-05-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Disease

Keywords

Heart, multiple organ dysfunction syndrome, pediatric critical care, congenital heart disease

Brief summary

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.

Interventions

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

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Days to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline intestinal epithelial barrier biomarker profile04/2016-01/31/2020
Microbiome diversity04/2016-01/31/2020

Secondary

MeasureTime frame
Multiple Organ Dysfunction Syndrome04/2016-01/31/2020

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026