Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05919940

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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