Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )

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.

Conditions

• ICU Acquired Weakness
• Muscle Atrophy
• Energy Malnutrition Protein
• Quality of Life
• Morphological and Microscopic Findings
• Metabolic Disturbance

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement: additional substitution of protein

Day one (admission) no nutrition is applied. Protein target is increased as follows: * to a level of 1,2g/kg/d on day 1 after ICU admission * to a level of 1,4g/kg/d on day 2 after ICU admission * to a level of 1,6g/kg/d on day 3 after ICU admission * to a level of 1,8g/kg/d on day 4 after ICU admission * to a level of 2,0g/kg/d from day 5 onwoards Additional protein is given within 2 hours after mobilization respectively: * to 0,125g/kg/d on day 1 after ICU admission * to 0,2g/kg/d on day 2 after ICU admission * to 0,25g/kg/d on day 3 after ICU admission * to 0,3g/kg/d from day 4 after ICU admission onwoards

DEVICE

Neuromuscular electrical stimulation

twice daily 60 minutes till day 28 or ICU discharge

OTHER

Early Mobilization

at least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge

Sponsors & Collaborators

• Fresenius Kabi

  collaborator INDUSTRY

• University Medicine Greifswald

  collaborator OTHER

• Berlin Institute of Health

  collaborator OTHER

• Universitätsklinikum Ulm

  collaborator UNKNOWN

• Medical University of Vienna

  collaborator OTHER

• Technical University of Munich

  lead OTHER

Principal Investigators

• Stefan J Schaller, MD · Medical University of Vienna & Charité - Universitätsmedizin Berlin

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-27

Primary Completion

2026-12-31

Completion

2027-01-31

Countries

• Austria
• Germany

Study Locations