About this trial

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.

Eligibility criteria

Qualifiers

critically ill adults (≥ 18 years of age)

newly admitted to the ICU (<48h)

mechanically ventilated, expected to remain for at least 72h

enteral nutrition is feasible

Disqualifiers

a BMI > 30

expected death or withdrawal of life-sustaining treatments

prior neuromuscular disease (e.g. paresis, myopathies, neuropathies)

injury or disease preventing neuromuscular electrical stimulation or early mobilization (e.g., elevated intracranial pressure, unstable spine)

Trial design

Treatments tested in this trial

  • Dietary Supplement: additional substitution of protein
  • Neuromuscular electrical stimulation
  • Early Mobilization

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

4
Austria
Medical University of Vienna1090, ViennaState of Vienna, Austria
Germany
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich81675, MunichBavaria, Germany
Charité - Universitätsmedizin Berlin10117, BerlinState of Berlin, Germany
Universitätsklinikum Ulm89070, Ulm Germany

Sponsors and collaborators

Technical University of Munich

Lead sponsor

Medical University of Vienna

Sponsor institution

Fresenius Kabi

Collaborator

University Medicine Greifswald

Collaborator

Berlin Institute of Health

Collaborator

Universitätsklinikum Ulm

Collaborator

Medical University of Vienna

Collaborator