Congenital Heart Disease Clinical Trial
— MOCHIOfficial title:
Muscle Catabolism and Its Impact on Functional Outcomes in Children Following Cardiac Surgery
NCT number | NCT04998643 |
Other study ID # | IRB-P00038896 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 15, 2022 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | June 1, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Academy of Nutrition and Dietetics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04992793 -
Paediatric Brain Injury Following Cardiac Interventions
|
||
Recruiting |
NCT05213598 -
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
|
||
Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
Completed |
NCT04814888 -
3D Airway Model for Pediatric Patients
|
||
Recruiting |
NCT04920643 -
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
|
N/A | |
Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A | |
Recruiting |
NCT06041685 -
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
|
N/A | |
Recruiting |
NCT05902013 -
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
|
N/A | |
Not yet recruiting |
NCT05687292 -
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
|
||
Not yet recruiting |
NCT05524324 -
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
|
N/A | |
Completed |
NCT02746029 -
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
|
||
Completed |
NCT02537392 -
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
|
N/A | |
Completed |
NCT03119090 -
Fontan Imaging Biomarkers (FIB) Study
|
||
Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
Terminated |
NCT02046135 -
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
|
Phase 2 | |
Completed |
NCT01966237 -
Milrinone Pharmacokinetics and Acute Kidney Injury
|
||
Recruiting |
NCT01184404 -
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
|
N/A | |
Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
Completed |
NCT01178710 -
Effect of Simvastatin on Cardiac Function
|
N/A |