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

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ClinicalTrials.gov Identifier: NCT02824705
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2016
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Katri Typpo, University of Arizona

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.


Condition or disease Intervention/treatment
Congenital Disease Procedure: Congenital Heart Disease Surgery

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity
Study Start Date : April 2016
Actual Primary Completion Date : January 1, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Congenital Heart Disease Surgery
    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 Outcome Measures :
  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 Outcome Measures :
  1. Multiple Organ Dysfunction Syndrome [ Time Frame: 04/2016-01/31/2020 ]

Biospecimen Retention:   Samples With DNA
Stool samples, blood samples with permission of family


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824705


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Katri Typpo, MD University of Arizona
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Responsible Party: Katri Typpo, Principal Investigator, University of Arizona
ClinicalTrials.gov Identifier: NCT02824705    
Other Study ID Numbers: NIDDK
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Katri Typpo, University of Arizona:
Heart
multiple organ dysfunction syndrome
pediatric critical care
congenital heart disease
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases