Cyanotic Congenital Heart DiseaseNCT05800691
Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.
An observational study of Cyanotic Congenital Heart Disease, run by Universitas Sumatera Utara at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Cyanotic Congenital Heart Disease
- How many people
- 197 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: The population of this study is CHD pediatric patients with a previous history of BT shunt procedure
Who may be able to join
- All CHD pediatric patients with a previous history of BT shunt procedure.
Who cannot join
- Pediatric patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Factors for Mortality in Patients After the Modified Blalock-Taussig Shunt Procedure in Developing Country: a Retrospective Study
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.
- Conditions
- Cyanotic Congenital Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Mortality
Death occured to patients during in hospital stay
Measured: November 2020 - January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Nov 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyanotic Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Principal investigator, Putri Amelia, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800691
- Sponsor's protocol ID
- 000
- Status last verified
- Aug 2023
- First submitted
- 12 Mar 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Factors for Mortality in Patients After the Modified Blalock-Taussig Shunt Procedure in Developing Country: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05800691
- Acronym / sponsor ID
- 000
- Conditions
- Cyanotic Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The population of this study is CHD pediatric patients with a previous history of BT shunt procedure
Key inclusion criteria (1 listed)
- All CHD pediatric patients with a previous history of BT shunt procedure.
Key exclusion criteria (1 listed)
- Pediatric patients with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-Hospital Mortality
Time frame: November 2020 - January 2021
Death occured to patients during in hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyanotic Congenital Heart Disease, run by Universitas Sumatera Utara at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Mortality (time frame: November 2020 - January 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.