Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.

Cyanotic Congenital Heart Disease Clinical Trial

Official title:

Predicting Factors for Mortality in Patients After the Modified Blalock-Taussig Shunt Procedure in Developing Country: a Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05800691
• Other study ID #: 000
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2023
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• All CHD pediatric patients with a previous history of BT shunt procedure.

Exclusion Criteria:

• Pediatric patients with incomplete medical records

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Indonesia	Universitas Sumatera Utara	Medan	North Sumatera

Sponsors (2)

Lead Sponsor	Collaborator
Universitas Sumatera Utara	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital Mortality	Death occured to patients during in hospital stay	November 2020 - January 2021