Muscle Catabolism and Outcomes in Children Following Cardiac Surgery

NCT04998643 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2023-07-19

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Muscle ultrasound to estimate lean body mass

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

Sponsors & Collaborators

Principal Investigators

  • Lori Bechard, RD, PhD · Boston Children's Hospital

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-12-30
Completion
2024-06-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998643 on ClinicalTrials.gov