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NCT03678909 Clinical Trial

Cardiac Biomarkers in Patients With Single Ventricle Physiology

Congenital Heart Disease Clinical Trial

Official title:
Cardiac Biomarkers in Patients With Single Ventricle Physiology

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03678909
Other study ID # H-42776
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date July 30, 2020

Study information
Verified date July 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Description:

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date July 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

Exclusion Criteria:

Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Locations
Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Mortality up to anticipated Glenn Procedure 3- 6 months depending on second stage procedure
Secondary NEC Incidence of Necrotizing enterocolitis 3- 6 months depending on second stage procedure
Secondary Reintubation Incidence of Reintubation 3- 6 months depending on second stage procedure
Secondary Cath intervention Incidence of cath interventions 3- 6 months depending on second stage procedure
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