Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02824705|
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2016
Last Update Posted : May 4, 2021
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
- 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.
- Change from baseline intestinal epithelial barrier biomarker profile [ Time Frame: 04/2016-01/31/2020 ]
- Microbiome diversity [ Time Frame: 04/2016-01/31/2020 ]
- Multiple Organ Dysfunction Syndrome [ Time Frame: 04/2016-01/31/2020 ]
Biospecimen Retention: Samples With DNA
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
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85719|
|Principal Investigator:||Katri Typpo, MD||University of Arizona|