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

September 27, 2021 updated by: Katri Typpo, University of Arizona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of infants and young children who are diagnosed with left sided obstructive congenital heart disease and are scheduled for corrective surgery. Investigators will enroll a total of 80 patients in this multi-center trial. Investigators anticipate that local enrollment will be about 1-2 patients per month, or 12-24 per year when the cardiac program is active.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline intestinal epithelial barrier biomarker profile
Time Frame: 04/2016-01/31/2020
04/2016-01/31/2020
Microbiome diversity
Time Frame: 04/2016-01/31/2020
04/2016-01/31/2020

Secondary Outcome Measures

Outcome Measure
Time Frame
Multiple Organ Dysfunction Syndrome
Time Frame: 04/2016-01/31/2020
04/2016-01/31/2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Katri Typpo, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDDK (DK092377)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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