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NCT01616394 Clinical Trial

Postoperative Troponin in Children With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01616394
Other study ID # 2011/07/DEC/460
Secondary ID
Status Completed
Phase N/A
First received February 8, 2012
Last updated November 18, 2014
Start date February 2012
Est. completion date October 2014

Study information
Verified date September 2013
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate the value of postoperative troponin in the prediction of mid term and long term mortality and morbidity in children with congenital heart disease undergoing cardiac surgery.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 10 Years
Eligibility Inclusion Criteria:

- all children with congenital heart disease between 0-10 years admitted for elective or emergency corrective or palliative cardiac surgery

Exclusion Criteria:

- parental refusal

- children older than 10 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Cliniques Universitaires saint Luc Brussels

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality 3 months Yes
Secondary morbidity and mortality and length of stay in the PICU and in the hospital in hospital; 3 months; 6 months Yes
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