NCT03990779

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

June 14, 2019

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    through study completion, an average 1-2 years

Secondary Outcomes (1)

  • Number of patients with major adverse outcomes after pediatric cardiac surgery

    through study completion, an average 1-2 years

Study Arms (1)

Children with congenital cardiac disease

Children with congenital cardiac disease who undergoing surgery

Diagnostic Test: Echocardiography

Interventions

EchocardiographyDIAGNOSTIC_TEST

Echocardiographic examination before and after cardiopulmonary bypass

Children with congenital cardiac disease

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric patients undergoing cardiac surgery

You may qualify if:

  • All pediatric patients undergoing cardiac surgery

You may not qualify if:

  • Applying extracorporeal membrane oxygenator prior to surgery
  • Trouble applying echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 19, 2019

Study Start

June 24, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations