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出境医 / 临床实验 / Echocardiography Findings and Perioperative Outcomes in Children

Echocardiography Findings and Perioperative Outcomes in Children

Study Description
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.

Condition or disease Intervention/treatment
Congenital Cardiac Defect Diagnostic Test: Echocardiography

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Children with congenital cardiac disease
Children with congenital cardiac disease who undergoing surgery
 Diagnostic Test: Echocardiography
Echocardiographic examination before and after cardiopulmonary bypass
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of patients with major adverse outcomes after pediatric cardiac surgery [ Time Frame: through study completion, an average 1-2 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Pediatric patients undergoing cardiac surgery
Criteria

Inclusion Criteria:

  • All pediatric patients undergoing cardiac surgery

Exclusion Criteria:

  • Applying extracorporeal membrane oxygenator prior to surgery
  • Trouble applying echocardiography
Contacts and Locations

Contacts
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Contact: Jin-Tae Kim, MD, PhD 82-2-2072-3661 jintae73@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Jin-Tae Kim, MD. PhD.    82-2-2072-3664    jintae73@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Tracking Information
First Submitted Date June 14, 2019
First Posted Date June 19, 2019
Last Update Posted Date March 29, 2021
Actual Study Start Date June 24, 2019
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 17, 2019) 		Number of patients with major adverse outcomes after pediatric cardiac surgery [ Time Frame: through study completion, an average 1-2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Echocardiography Findings and Perioperative Outcomes in Children
Official Title Echocardiography Findings and Perioperative Outcomes in Children Undergoing Congenital Heart Surgery: Prospective Observational Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pediatric patients undergoing cardiac surgery
Condition Congenital Cardiac Defect
Intervention Diagnostic Test: Echocardiography
Echocardiographic examination before and after cardiopulmonary bypass
Study Groups/Cohorts Children with congenital cardiac disease
Children with congenital cardiac disease who undergoing surgery
Intervention: Diagnostic Test: Echocardiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2019) 		400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All pediatric patients undergoing cardiac surgery

Exclusion Criteria:

  • Applying extracorporeal membrane oxygenator prior to surgery
  • Trouble applying echocardiography
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jin-Tae Kim, MD, PhD 82-2-2072-3661 jintae73@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03990779
Other Study ID Numbers H1906-031-1038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date March 2021

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