Reduction of Muscle Catabolism Through Brain Activation in Burn Patients

NCT07435402 | Not Yet Recruiting

• 1 other identifier: REMBRANT-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Burns - Multiple; Critical Illness; Muscle Weakness

Keywords

extensive burn injury; skeletal muscle wasting; brain activation

Outcome Measures

Primary Outcomes (3)

• 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).

  From baseline (within first 7 days after ICU admission) up to 24 weeks.

• 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).

  From baseline (day 10 after injury) to day 30 after injury

• 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.

  From baseline (within first 7 days after ICU admission) up to 24 weeks.

Secondary Outcomes (8)

• Intensive care unit length of stay

  From ICU admission up to 24 weeks.

• Ventilator-free days

  From ICU admission up to 24 weeks.

• Mitochondrial oxidative phosphorylation capacity

  Days 10, 20, and 30 after injury

• Myokine profiles

  During hospitalization (days 10, 20, and 30 after injury).

• Cognitive function assessed using the Montreal Cognitive Assessment (MoCA). The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive performance.

  At hospital discharge, 3 months, and 6 months after discharge.

Study Arms (2)

Propofol Group

NO INTERVENTION

Standard Burn Care with Intravenous Sedation

Isoflurane Group

EXPERIMENTAL

Burn-Bundle Extended Rehabilitation Program with Isoflurane Sedation

Other: Burn-Bundle Extended Rehabilitation Program; Drug: Isoflurane Inhalational Sedation; Device: Functional Proprioceptive Stimulation; Device: Neurorehabilitation Techniques

Interventions

Burn-Bundle Extended Rehabilitation Program OTHER

A 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 Group

Isoflurane Inhalational Sedation DRUG

Sedation with inhaled isoflurane administered via an anesthetic conserving device during invasive mechanical ventilation, used as an alternative to standard intravenous sedatives.

Isoflurane Group

Functional Proprioceptive Stimulation DEVICE

Illusory movements induced by focal vibration of muscle attachments to activate central motor pathways, applied twice daily during the acute phase of critical illness.

Isoflurane Group

Neurorehabilitation Techniques DEVICE

Non-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.

Isoflurane Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to obtain written informed consent from the patient or a legally authorized representative

You may not qualify if:

• 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
• Any condition that, in the opinion of the investigator, would make participation in the study unsafe or interfere with protocol adherence

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Masaryk University: collaborator

Study Sites (1)

University Hospital Královské Vinohrady

Prague, Česká Republika, 100 34, Czechia

Location

Related Publications (1)

• No publications available at this time.

  BACKGROUND

Related Links

• General information about the study and study site

MeSH Terms

Conditions

Critical Illness; Muscle Weakness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Bohumil Bakalář, MD, PhD

  University Hospital Kralovske Vinohrady Praha Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bohumil Bakalář, MD, PhD

CONTACT

+420 728816095; bohumil.bakalar@lf3.cuni.cz

Břetislav Lipový, MD, PhD, MBA

CONTACT

+420 26716 3392; bretislav.lipovy@fnkv.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a control group receiving standard burn care and conventional rehabilitation with intravenous sedation, and an intervention group receiving standard burn care plus the Burn-Bundle Extended Rehabilitation Program, including inhalational isoflurane sedation and multimodal neurorehabilitation. Participants will remain in their assigned group for the duration of the study.

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning after publication of the primary study results.
• Access Criteria: Access to de-identified individual participant data will be granted upon reasonable request for scientifically valid research proposals, subject to approval by the study investigators and completion of appropriate data use agreements.

Locations

CZ (1)