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Perioperative changes of muscle mass measured by ultrasound in pediatric patients with congenital heart defects and the impact of sarcopenia on postoperative outcomes: prospective observational study

Status Approved

First Submitted Date

2019/02/06
Registered Date

2019/03/18
Last Updated Date

2019/03/05

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003634
Unique Protocol ID	2019-0080
Public/Brief Title	Changes in muscle mass measured by ultrasound in children undergoing cardiac surgery and the effect of sarcopenia on prognosis
Scientific Title	Perioperative changes of muscle mass measured by ultrasound in pediatric patients with congenital heart defects and the impact of sarcopenia on postoperative outcomes: prospective observational study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2019-0080
Approval Date	2019-01-18
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	In-Kyung Song
Title	Assistant professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL 05505
Contact Person for Public Queries
Name	In-Kyung Song
Title	Assistant professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL 05505
Contact Person for Updating Information
Name	In-Kyung Song
Title	Assistant professor
Telephone	+82-2-3010-3868
Affiliation	Asan Medical Center
Address	88, OLYMPIC-RO 43-GIL, SONGPA-GU, SEOUL 05505

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-04-01 Anticipated
Target Number of Participant	100
Primary Completion Date	2020-02-29 , Anticipated
Study Completion Date	2020-03-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-04-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Asan Medical Center
Organization Type	Medical Institute
Project ID	2019-0080

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Skeletal muscle mass is an important factor in the prognosis and recovery of acute and chronic diseasess. Sarcopenia, defined as an unintended loss of skeletal muscle, is a reliable biological indicator of nutritional status. It has been reported that skeletal muscle loss occurs in patients with severe liver disease in children, and the prognosis is poorer in patients undergoing cardiac surgery when they are low weight. Because children with congenital heart disease are at high risk of energy imbalance, malnutrition and growth disorders, various efforts are being made to improve nutritional status before and after surgery. Recently, it has become possible to quantify muscle mass with ulgrasound and the thickness of the rectus femoris muscle and quadriceps muscle measured by ultrasound can be useful in critically-ill adults and children. The purpose of this study was to evaluate the prevalence of sarcopenia measured by muscle ultrasound before and after surgery in pediatric cardiac patients and to assess the effect of sarcopenia on the postoperative outcome. All subjects receive muscle ultrasound measurements three times; after the induction of general anesthesia, within postoperative 24 hours, and before the hospital discharge. The thickness and cross-sectional area of the rectus femoris muscle and the thickness of quadriceps muscle are compared.

Study Summary Information

Lay Summary

Skeletal muscle mass is an important factor in the prognosis and recovery of acute and chronic diseasess. Sarcopenia, defined as an unintended loss of skeletal muscle, is a reliable biological indicator of nutritional status. It has been reported that skeletal muscle loss occurs in patients with severe liver disease in children, and the prognosis is poorer in patients undergoing cardiac surgery when they are low weight. Because children with congenital heart disease are at high risk of energy imbalance, malnutrition and growth disorders, various efforts are being made to improve nutritional status before and after surgery. Recently, it has become possible to quantify muscle mass with ulgrasound and the thickness of the rectus femoris muscle and quadriceps muscle measured by ultrasound can be useful in critically-ill adults and children. The purpose of this study was to evaluate the prevalence of sarcopenia measured by muscle ultrasound before and after surgery in pediatric cardiac patients and to assess the effect of sarcopenia on the postoperative outcome. All subjects receive muscle ultrasound measurements three times; after the induction of general anesthesia, within postoperative 24 hours, and before the hospital discharge. The thickness and cross-sectional area of the rectus femoris muscle and the thickness of quadriceps muscle are compared.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	100
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Pediatric patients undergoing cardiac surgery
Cohort/ Group 1	Cohort/Group Description The thickness and cross-sectional area of the rectus femoris muscle and the thickness of quadriceps muscle are measured by ultrasound.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Pediatric patients under the age of five, scheduled for cardiac surgery at Asan Medical Center
Sampling Method	Consecutive sampling of subjects who meet the inclusion criteria from the study population
Condition(s)/Problem(s)	* (Q00-Q99)Congenital malformations, deformations and chromosomal abnormalities (Q24.9)Congenital malformation of heart, unspecified Heart Defects, Congenital
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 0Year~5Year
	Description - Pediatric patients under the age of five, scheduled for cardiac surgery due to congenital heart disease - Both parents agreed to participate in the study spontaneoulsy
Exclusion Criteria	- History of prematurity (Gestational age<37 weeks) - Low weight below the 5th percentile defined by The 2017 Korean National Growth Charts for children and adolescents - Chromosomal or genetic abnormality - Congenital disease other than congenital heart disease - Growth or eating disorder - Cardiac surgery not using cardiopulmonary bypass - Deemed inappropriate by the researcher
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Thickness and cross-sectional area of rectus femoris and thickness of quadriceps femoris
Timepoint	After induction of general anesthesia, within postoperative 24 hours, before hospital discharge
Secondary Outcome(s) 1
Outcome	Operation time, anesthesia time, cardiopulmonary bypass time
Timepoint	At the end of surgery
Secondary Outcome(s) 2
Outcome	Weight on the date of muscle ultrasound measurement
Timepoint	Before performing muscle ultrasound
Secondary Outcome(s) 3
Outcome	Total intraoperative input and output
Timepoint	At the end of surgery
Secondary Outcome(s) 4
Outcome	Postoperative daily input and output
Timepoint	Midnight every day after the surgery
Secondary Outcome(s) 5
Outcome	Duration of mechanical ventilation, intensive care unit stay, and hospital stay
Timepoint	After hospital discharge
Secondary Outcome(s) 6
Outcome	Incidence of postoperative complications
Timepoint	After hospital discharge

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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