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.
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
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)
Parallel
Dietary Supplement: additional substitution of protein
Dietary supplementDay 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
Neuromuscular electrical stimulation
Devicetwice daily 60 minutes till day 28 or ICU discharge
Early Mobilization
Other interventionat least 20 minutes a day following the SOMS concept. Duration: till 28 day or ICU discharge
Change in cross sectional area (ΔCSA) of the rectus femoris
Change in muscle mass between study inclusion and study day 14; measured as change of the cross sectional area (ΔCSA) of the rectus femoris muscle via ultrasound.
change in muscle thickness of the rectus femoris
change in muscle thickness from study inclusion until 90-day follow-up, measured via ultrasound.
change in echogenicity of the rectus femoris
change in echogenicity from study inclusion until 90-day follow-up, measured via ultrasound.
change of the pennation angle of the rectus femoris
change of the pennation angle from study inclusion until 90-day follow-up, measured via ultrasound.
change of the muscle strength, measured by the Medical Research Council score (MRC-score)
change of the muscle strength, measured by the Medical Research Council score (MRC-score) from study inclusion until 90-day follow-up
in-hospital mortality
Mortality during the Hospital stay
Hospital LOS
Length of stay in the hospital
ICU-LOS
Length of stay in the ICU
Hospital mortality
Mortality during Hospital stay
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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
