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

Sponsor
Universitas Sumatera Utara (Other)
Overall Status
Completed
CT.gov ID
NCT05800691
Collaborator
Indonesia University (Other)
197
Enrollment
1
Location
3
Actual Duration (Months)
65.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    197 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Predicting Factors for Mortality in Patients After the Modified Blalock-Taussig Shunt Procedure in Developing Country: a Retrospective Study
    Actual Study Start Date :
    Nov 1, 2020
    Actual Primary Completion Date :
    Jan 31, 2021
    Actual Study Completion Date :
    Jan 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. In-Hospital Mortality [November 2020 - January 2021]

      Death occured to patients during in hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • All CHD pediatric patients with a previous history of BT shunt procedure.
    Exclusion Criteria:
    • Pediatric patients with incomplete medical records

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitas Sumatera Utara Medan North Sumatera Indonesia 20155

    Sponsors and Collaborators

    • Universitas Sumatera Utara
    • Indonesia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Putri Amelia, dr. Putri Amelia, M.Ked (Ped), Sp.A(K), Universitas Sumatera Utara
    ClinicalTrials.gov Identifier:
    NCT05800691
    Other Study ID Numbers:
    • 000
    First Posted:
    Apr 5, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Apr 5, 2023