Muscle Catabolism and Outcomes in Children Following Cardiac Surgery (MOCHI)

Muscle Catabolism and Its Impact on Functional Outcomes in Children Following Cardiac Surgery

Background & Significance. Children with congenital heart disease (CHD) have experienced improved postoperative survival shifting the focus away from minimizing mortality to curtailing morbidities. Critical illness following cardiac surgery induces catabolism which may impact functional status. Catabolism, a state in which protein breakdown exceeds protein synthesis, can lead to lean body mass (LBM) breakdown. LBM loss has been associated with poor clinical outcomes. Muscle ultrasound (mUS) has been utilized to measure LBM changes and the functional status score (FSS) was developed to assess functional status changes in children following hospitalization. The ability to identify LBM loss acutely and its association with FSS changes may lead to earlier interventions to preserve LBM and aid in outcome prediction.

Specific Aims & Hypotheses. Specific Aim 1 is to identify the percent change in LBM by mUS during the first postoperative week in children following complex cardiac surgery. Specific Aim 2 is to evaluate the relationship between percent change in LBM during the first postoperative week and the FSS at discharge and 6 and 12-month follow-up in children with CHD following complex cardiac surgery. The investigators hypothesize children with CHD following complex cardiac surgery will experience a decline in LBM and that there is a direct relationship between the change in LBM and postoperative FSS follow-up.

Study Design & Methods. The investigators are conducting a single-center, prospective, observational cohort study. Consecutive children (> 3 months and < 18 years of age) with CHD undergoing biventricular conversion will be enrolled. Patients will undergo a baseline mUS and FSS at the time of the index operation. Interval mUS will be obtained on the third and seventh postoperative day. Discharge mUS and FSS will be obtained and a remote FSS will be requested by the family at 6 and 12-months postoperatively. Demographics, pertinent laboratory, concomitant medications, nutrition and ultrasound variables will be collected.

Outcomes. The primary outcomes will be change in LBM during the first postoperative week and change in FSS at 6 and 12-month follow-up in children following complex cardiac surgery. Change in LBM will be defined as a percent change in cross-sectional area of the quadriceps muscle layer thickness (QMLT). Change in FSS will be significant if the score drops 3 points or more from baseline at postoperative follow-up.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; ICU Acquired Weakness; Catabolic State
• Intervention / Treatment: Diagnostic test: Muscle ultrasound to estimate lean body mass

Detailed Description

The central objective of our single center, pilot study in children with CHD following cardiac surgery is to identify serial changes in QMLT, as an estimate of LBM, during the first postoperative week, and to examine its relationship to functional status, assessed by FSS, after hospital discharge.

Primary Aim 1. To measure the percent change in QMLT by mUS during the first postoperative week in children undergoing complex cardiac surgery. The investigators hypothesize children undergoing complex cardiac surgery will have a mean decline of at least 10% in QMLT during the first postoperative week.

Primary Aim 2. To examine the relationship between percent change in QMLT during the first postoperative week and FSS at 3 and 6-months. The investigators hypothesize there is a direct relationship between percent change in QMLT during the first postoperative week and FSS at 3 and 6-months following surgery.

Secondary Aim 1. To explore the relationship between nitrogen balance, defined as the difference between total nitrogen intake and total urinary nitrogen loss, and mean change in QMLT during the first postoperative week. The investigators hypothesize there is a direct correlation between nitrogen balance and mean change in QMLT during the first postoperative week in children following complex cardiac surgery.

The proposed utilization of mUS to measure alterations in body composition during the acute phase of critical illness may provide early prediction of subsequent functional status decline.

• Study Type: Observational
• Enrollment (Estimated): 64

Contacts and Locations

• Study Contact: Name: Kimberly I Mills, MD; Phone Number: 6173554023; Email: kimberly.mills@cardio.chboston.org
• Study Contact Backup: Name: Lori Bechard, RD,PhD; Phone Number: 6173556000; Email: lori.bechard@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Kimberly I Mills, MD; Phone Number: 617-355-7866; Email: kimberly.mills@cardio.chboston.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with congenital heart disease admitted to the cardiac intensive care unit following complex cardiac surgery.

Description

Inclusion Criteria:

1. children > 3 months and < 18 years old,
2. diagnosed with CHD, and
3. undergoing biventricular conversion.

Exclusion Criteria:

1. diagnosis of muscular dystrophy or myopathy,
2. lower extremity injury or infection during the current hospitalization,
3. enrolled in a concurrent nutritional intervention trial, or
4. admitted for palliative care.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lean body mass	The investigators are measuring the change in lean body mass estimated by quadriceps muscle layer thickness (QMLT)	7 days postoperatively
Change in functional status	The investigators will measure functional status at 6 and 12-month follow-up to investigate the association between change in QMLT and functional status	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship of nitrogen balance to lean body mass changes	The investigators will measure urinary nitrogen balance to investigate its relationship to mean change in QMLT during the first postoperative week	12-24 hours postoperatively

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Academy of Nutrition and Dietetics
• Investigators: Study Director: Lori Bechard, RD, PhD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB-P00038896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No