Congenital Heart DiseaseMOCHINCT04998643
Muscle Catabolism and Outcomes in Children Following Cardiac Surgery
An observational study of Congenital Heart Disease and ICU Acquired Weakness, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Congenital Heart Disease, ICU Acquired Weakness, Catabolic State
- What is being tested?
- Muscle ultrasound to estimate lean body mass
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with congenital heart disease admitted to the cardiac intensive care unit following complex cardiac surgery.
Who may be able to join
- children > 3 months and < 18 years old,
- diagnosed with CHD, and
- undergoing biventricular conversion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Kimberly I Mills, MD, 617-355-7866, kimberly.mills@cardio.chboston.org
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Muscle ultrasound to estimate lean body mass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle ultrasound to estimate lean body massDiagnostic test
The investigators will perform serial muscle ultrasounds in the postoperative period to estimate lean body mass.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean body mass
The investigators are measuring the change in lean body mass estimated by quadriceps muscle layer thickness (QMLT)
Measured: 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
Measured: 6 and 12 months
Secondary outcomes (1)
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
Measured: 12-24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Jul 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Principal investigator, Kimberly I. Mills, MD, Boston Children's Hospital
- Investigators
- Lori Bechard, RD, PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998643
- Sponsor's protocol ID
- IRB-P00038896
- Acronym
- MOCHI
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Catabolism and Its Impact on Functional Outcomes in Children Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04998643
- Acronym / sponsor ID
- MOCHI / IRB-P00038896
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with congenital heart disease admitted to the cardiac intensive care unit following complex cardiac surgery.
Key inclusion criteria (3 listed)
- children > 3 months and < 18 years old,
- diagnosed with CHD, and
- undergoing biventricular conversion.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle ultrasound to estimate lean body massThe investigators will perform serial muscle ultrasounds in the postoperative period to estimate lean body mass. | Diagnostic test | – |
Primary outcome
Change in lean body mass
Time frame: 7 days postoperatively
The investigators are measuring the change in lean body mass estimated by quadriceps muscle layer thickness (QMLT)
Change in functional status
Time frame: 6 and 12 months
The investigators will measure functional status at 6 and 12-month follow-up to investigate the association between change in QMLT and functional status
1 secondary outcome
Relationship of nitrogen balance to lean body mass changes
Time frame: 12-24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No. Participant data will not be shared with other researchers.
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Bechard, RD, PhD study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and ICU Acquired Weakness, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly I Mills, MD (6173554023, kimberly.mills@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean body mass (time frame: 7 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.