Outcome of Patients With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— OUTCARDIOP  

Official title:

Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913520
• Other study ID #: 2019/12FEV/072
• Status: Completed
• Phase: N/A
• Start date: April 28, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

Description:

Previous studies have shown that children and adults presenting with congenital heart disease are at increased risk of morbidity and mortality after non-cardiac interventions. This risk depends on the type of pathology, the age of the patient and the experience of the physicians in charge of these patients. We sought to determine the prevalence of children and adults with congenital heart disease presenting for non-cardiac interventions and to investigate their outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All children and adults with congenital heart disease

Exclusion Criteria:

• Parental or patient refusal
• Patients presenting for cardiac interventions

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Outcome research
patients will undergo an evaluation of their outcome at 30 days postoperatively

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	The prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a single-centre tertiary hospital	To analyze the exact number of children and adults with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital	Intraoperative
Secondary	To analyze morbidity after non-cardiac interventions in patients with congenital heart disease	Morbidity outcome after non-cardiac interventions	30 days
Secondary	To analyze mortality after non-cardiac interventions in patients with congenital heart disease	Mortality outcome after non-cardiac interventions	30 days