RecruitingNot ApplicableNCT05919940

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

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


Sponsor

Technical University of Munich

Enrollment

40 participants

Start Date

Jun 27, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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)
  • a pacemaker or other electronic implant
  • allergy to components of NMES adhesive
  • have been dependent during activities of daily living prior to the hospital admission
  • a language barrier

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Interventions

DIETARY_SUPPLEMENTDietary 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

DEVICENeuromuscular electrical stimulation

twice daily 60 minutes till day 28 or ICU discharge

OTHEREarly Mobilization

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


Locations(4)

Medical University of Vienna

Vienna, State of Vienna, Austria

Klinikum rechts der Isar, School of Medicine, Technical Universtity of Munich

Munich, Bavaria, Germany

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Universitätsklinikum Ulm

Ulm, Germany

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NCT05919940