Reduction of Muscle Catabolism Through Brain Activation in Burn Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this trial
Patients with extensive burn injuries frequently develop severe skeletal muscle wasting and weakness as part of critical illness-related myopathy and neuropathy. This condition delays ventilator weaning, prolongs intensive care unit (ICU) and hospital stay, and contributes to long-term functional impairment and reduced quality of life. In burn patients, muscle loss is particularly pronounced during the early post-injury phase and is associated with mitochondrial dysfunction and altered neuromuscular signaling.
Effective strategies to prevent muscle catabolism in critically ill burn patients remain limited. Although early active rehabilitation is beneficial, many patients are unable to participate due to deep sedation, mechanical ventilation, or clinical instability. Therefore, innovative rehabilitation approaches applicable during the acute phase of critical illness are needed.
The REMBRANT (REduction of Muscle catabolism through BRAin activation in burn patieNTs) study is a single-center, randomized, controlled, open-label clinical trial evaluating whether a multimodal brain-activating rehabilitation strategy can attenuate skeletal muscle loss in adult patients with severe burns. Thirty patients with burns involving more than 30% of total body surface area who require invasive mechanical ventilation and prolonged sedation will be randomized in a 1:1 ratio to standard care or an intervention group.
Both groups will receive standardized burn treatment and conventional rehabilitation. The intervention group will additionally receive the Burn-Bundle Extended Rehabilitation Program, combining inhalational isoflurane sedation with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when clinically feasible.
The primary outcome is change in skeletal muscle mass and strength. Secondary outcomes include ICU length of stay, ventilator-free days, mitochondrial function, and health-related quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Severe burn injury involving more than 30% of total body surface area (TBSA)
Admission to the intensive care unit
Expected need for invasive mechanical ventilation and continuous sedation for at least 7 days
Disqualifiers
Pre-existing severe neuromuscular or neurodegenerative disease
Known contraindication to inhalational sedation with isoflurane
Pregnancy or breastfeeding
Participation in another interventional clinical trial that could interfere with the study outcomes
Trial design
Design model
Parallel
Treatments tested in this trial
Burn-Bundle Extended Rehabilitation Program
Other interventionA multimodal brain-activating rehabilitation program consisting of inhalational isoflurane sedation combined with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when consciousness allows, applied during the acute phase after severe burn injury.
Isoflurane Inhalational Sedation
DrugSedation with inhaled isoflurane administered via an anesthetic conserving device during invasive mechanical ventilation, used as an alternative to standard intravenous sedatives.
Functional Proprioceptive Stimulation
DeviceIllusory movements induced by focal vibration of muscle attachments to activate central motor pathways, applied twice daily during the acute phase of critical illness.
Neurorehabilitation Techniques
DeviceNon-invasive neurorehabilitation techniques including repetitive transcranial magnetic stimulation and virtual reality-assisted rehabilitation applied to enhance cortical activation and neuroplasticity in critically ill burn patients when clinically feasible.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Propofol GroupNo intervention 0 interventions
Group B: Isoflurane GroupExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in skeletal muscle mass assessed by dual-energy X-ray absorptiometry (DEXA)
Change in lean body mass measured by dual-energy X-ray absorptiometry. Lean mass is reported in kilograms (kg).
Time frame
From baseline (within first 7 days after ICU admission) up to 24 weeks.2
Change in rectus femoris muscle thickness assessed by ultrasound
Change in rectus femoris muscle thickness measured by ultrasound. Muscle thickness is reported in millimeters (mm).
Time frame
From baseline (day 10 after injury) to day 30 after injury3
Change in muscle strength assessed by the Medical Research Council (MRC) Sum Score
Muscle strength assessed using the Medical Research Council (MRC) Sum Score. The MRC Sum Score ranges from 0 to 60, with higher scores indicating greater muscle strength.
Time frame
From baseline (within first 7 days after ICU admission) up to 24 weeks.Secondary outcomes
1
Intensive care unit length of stay
Length of stay in the intensive care unit measured in days.
Time frame
From ICU admission up to 24 weeks.2
Ventilator-free days
Number of days alive and free from invasive mechanical ventilation during the ICU stay.
Time frame
From ICU admission up to 24 weeks.3
Mitochondrial oxidative phosphorylation capacity
Oxidative phosphorylation capacity measured by high-resolution respirometry in skeletal muscle biopsy samples. Results reported as oxygen flux (pmol O2·s-¹·mg-¹).
Time frame
Days 10, 20, and 30 after injury4
Myokine profiles
Plasma concentrations of selected myokines measured using multiplex immunoassays. Results reported in pg/mL.
Time frame
During hospitalization (days 10, 20, and 30 after injury).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Charles University, Czech Republic
Lead sponsor
Masaryk University
Collaborator
Source ClinicalTrials.gov
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