Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution: a Randomized, Outcome-assessor Blinded, Proof-of-concept Study (IMEMPRO)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Device, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich
ACTIVE_NOT_RECRUITING
Munich
Universitätsklinikum Ulm
RECRUITING
Ulm
Contact Information
Primary
Stefan J Schaller, MD
s.schaller@tum.de
+498941409635
Backup
Kristina Fuest, MD
kristina.fuest@tum.de
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 40
Treatments
Experimental: Intervention
High protein substitution plus NMES and EM
No_intervention: Control Group
Nutrition and mobilization are carried out according to standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: Fresenius Kabi, Berlin Institute of Health, Medical University of Vienna, Universitätsklinikum Ulm, University Medicine Greifswald
Leads: Technical University of Munich

This content was sourced from clinicaltrials.gov