Assessing muscle loss in children after heart surgery
Muscle Catabolism and Its Impact on Functional Outcomes in Children Following Cardiac Surgery
Boston Children's Hospital · NCT04998643
This study looks at how much muscle kids with congenital heart disease lose after heart surgery to see if it affects their recovery and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04998643 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with congenital heart disease (CHD) who undergo complex cardiac surgery. It aims to measure changes in lean body mass (LBM) using muscle ultrasound during the first week post-surgery and to evaluate how these changes relate to functional status over the following months. By identifying LBM loss early, the study seeks to facilitate timely interventions that could improve patient outcomes. The relationship between nitrogen balance and LBM changes will also be explored.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 18 years diagnosed with congenital heart disease undergoing biventricular conversion.
Not a fit: Patients with muscular dystrophy, lower extremity injuries, or those receiving palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for children after cardiac surgery, enhancing their functional outcomes.
How similar studies have performed: While the approach of using muscle ultrasound to assess LBM changes is innovative, similar studies have shown promise in understanding muscle loss in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Kimberly I Mills, MD
- Email: kimberly.mills@cardio.chboston.org
- Phone: 6173554023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Heart Disease, ICU Acquired Weakness, Catabolic State