Congenital Cardiac DefectNCT03990779
Echocardiography Findings and Perioperative Outcomes in Children
An observational study of Congenital Cardiac Defect, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Cardiac Defect
- What is being tested?
- Echocardiography
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2019to 30 Dec 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric patients undergoing cardiac surgery
Who may be able to join
- All pediatric patients undergoing cardiac surgery
Who cannot join
- Applying extracorporeal membrane oxygenator prior to surgery
- Trouble applying echocardiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study
This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing surgery for congenital cardiac disease. Echocardiographic findings include the doppler patterns of hepatic vein, portal vein, renal artery, renal vein and splenic vein before and after cardiopulmonary bypass. Portal pulsatility index, renal resistive index, and respiratory variations in peak aortic blood flow velocity and diameter of inferior vena cava are measured.
- Conditions
- Congenital Cardiac Defect
- Being tested
- Echocardiography
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiographic examination before and after cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Children with congenital cardiac disease | Children with congenital cardiac disease who undergoing surgery Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of Doppler values and its derived parameters of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography in children with congenital cardiac disease
To find the characteristics and standard values of Doppler findings measured by echocardiography before and after congenital cardiac surgery
Measured: after anesthetic induction until the end of surgery
Association between Doppler values measured by echocardiography and clinical outcomes after pediatric cardiac surgery
To evaluate whether Doppler values of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography can predict major adverse outcomes after pediatric cardiac surgery
Measured: through study completion, an average 1-2 years
Secondary outcomes (1)
Number of patients with major adverse outcomes after pediatric cardiac surgery
Measured: through study completion, an average 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start24 Jun 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Cardiac DefectStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990779
- Sponsor's protocol ID
- H1906-031-1038
- Status last verified
- May 2022
- First submitted
- 14 Jun 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JH, Denault AY, Beaubien-Souligny W, Kang P, Kim J, Kim HW, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Higher portal venous pulsatility is associated with worse clinical outcomes following congenital heart surgery: a single-centre prospective cohort study. Can J Anaesth. 2023 Dec;70(12):1957-1969. doi: 10.1007/s12630-023-02605-0. Epub 2023 Nov 2.
PubMed 37919629
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03990779
- Acronym / sponsor ID
- H1906-031-1038
- Conditions
- Congenital Cardiac Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 Jun 2019 (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.
This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing surgery for congenital cardiac disease. Echocardiographic findings include the doppler patterns of hepatic vein, portal vein, renal artery, renal vein and splenic vein before and after cardiopulmonary bypass. Portal pulsatility index, renal resistive index, and respiratory variations in peak aortic blood flow velocity and diameter of inferior vena cava are measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with congenital cardiac disease | – | Diagnostic Test: EchocardiographyChildren with congenital cardiac disease who undergoing surgery |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing cardiac surgery
Key inclusion criteria (1 listed)
- All pediatric patients undergoing cardiac surgery
Key exclusion criteria (2 listed)
- Applying extracorporeal membrane oxygenator prior to surgery
- Trouble applying echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiographic examination before and after cardiopulmonary bypass | Diagnostic test | Children with congenital cardiac disease |
Primary outcome
Characteristics of Doppler values and its derived parameters of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography in children with congenital cardiac disease
Time frame: after anesthetic induction until the end of surgery
To find the characteristics and standard values of Doppler findings measured by echocardiography before and after congenital cardiac surgery
Association between Doppler values measured by echocardiography and clinical outcomes after pediatric cardiac surgery
Time frame: through study completion, an average 1-2 years
To evaluate whether Doppler values of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography can predict major adverse outcomes after pediatric cardiac surgery
1 secondary outcome
Number of patients with major adverse outcomes after pediatric cardiac surgery
Time frame: through study completion, an average 1-2 years
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 5 May 2022.
- Derived from this study: PubMed 37919629Lee JH, Denault AY, Beaubien-Souligny W, Kang P, Kim J, Kim HW, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Higher portal venous pulsatility is associated with worse clinical outcomes following congenital heart surgery: a single-centre prospective cohort study. Can J Anaesth. 2023 Dec;70(12):1957-1969. doi: 10.1007/s12630-023-02605-0. Epub 2023 Nov 2.
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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 Congenital Cardiac Defect, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 5 May 2022. 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 South Korea. 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?
Characteristics of Doppler values and its derived parameters of portal vein, hepatic vein, renal artery and vein, and splenic vein measured using echocardiography in children with congenital cardiac disease (time frame: after anesthetic induction until the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990779, which also lists 1 linked publication.
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 5 May 2022.