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Completed

NCT Number: NCT03990779

Echocardiography Findings and Perioperative Outcomes in Children

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.

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Key information

Conditions

Congenital Cardiac Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pediatric patients undergoing cardiac surgery

Exclusion criteria

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

Treatment and study plan

Echocardiography

Diagnostic Test

Echocardiographic examination before and after cardiopulmonary bypass

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Number of patients with major adverse outcomes after pediatric cardiac surgery

    Time frame: through study completion, an average 1-2 years

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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