Clinical Trial

Reduction of Muscle Catabolism Through Brain Activation in Burn Patients

Study acronym: REMBRANT
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07435402
Lead Sponsor Charles University, Czech Republic
Collaborators: Masaryk University
Conditions Burns - Multiple, Critical Illness, Muscle Weakness
Enrollment 30 participants
Start Date 2026-05-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-27