Muscle Catabolism and Outcomes in Children Following Cardiac Surgery

NCT04998643 | Unknown

• 1 other identifier: IRB-P00038896
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease; ICU Acquired Weakness; Catabolic State

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Relationship of nitrogen balance to lean body mass changes

  12-24 hours postoperatively

Interventions

Muscle ultrasound to estimate lean body mass DIAGNOSTIC_TEST

The investigators will perform serial muscle ultrasounds in the postoperative period to estimate lean body mass.

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine collection

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lori Bechard, RD, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Kimberly I Mills, MD

CONTACT

6173554023; kimberly.mills@cardio.chboston.org

Lori Bechard, RD,PhD

CONTACT

6173556000; lori.bechard@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 10, 2021
• Study Start: July 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: June 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)