Actively Recruiting
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
Led by Technical University of Munich · Updated on 2026-03-03
40
Participants Needed
4
Research Sites
187 weeks
Total Duration
On this page
Sponsors
T
Technical University of Munich
Lead Sponsor
F
Fresenius Kabi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients. The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline. The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.
CONDITIONS
Official Title
Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Critically ill adults 18 years of age or older
- Newly admitted to the ICU within the past 48 hours
- Mechanically ventilated and expected to remain so for at least 72 hours
- Able to receive enteral nutrition
You will not qualify if you...
- Body mass index (BMI) greater than 30
- Expected death or plans to withdraw life-sustaining treatments
- Prior neuromuscular diseases such as paresis, myopathies, or neuropathies
- Injury or condition preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)
- Presence of pacemaker or other electronic implants
- Allergy to components of the neuromuscular electrical stimulation adhesive
- Dependence in activities of daily living before hospital admission
- Language barrier preventing communication
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Medical University of Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
2
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich
Munich, Bavaria, Germany, 81675
Active, Not Recruiting
3
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117
Active, Not Recruiting
4
Universitätsklinikum Ulm
Ulm, Germany, 89070
Actively Recruiting
Research Team
S
Stefan J Schaller, MD
CONTACT
M
Marian Demitsch
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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