Echocardiography Findings and Perioperative Outcomes in Children

Congenital Cardiac Defect Clinical Trial

Official title:

Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990779
• Other study ID #: H1906-031-1038
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All pediatric patients undergoing cardiac surgery

Exclusion Criteria:

• Applying extracorporeal membrane oxygenator prior to surgery

• Trouble applying echocardiography

Related Conditions & MeSH terms

• Congenital Cardiac Defect
• Heart Defects, Congenital

Intervention

Diagnostic Test:
• Echocardiography
Echocardiographic examination before and after cardiopulmonary bypass

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of patients with major adverse outcomes after pediatric cardiac surgery		through study completion, an average 1-2 years