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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Jan 31, 2026 to Jan 31, 2027
    • Site details revised at 1 of 4 sites
    v8
  2. Minor Study sites: 3 to 4
    • Collaborators: 4 to 5
    v7
  3. Minor Study sites: 2 to 3
    • Collaborators: 3 to 4
    v6
  4. Notable Primary completion date: Oct 31, 2024 to Dec 31, 2025
    • Study completion date: Jan 15, 2025 to Jan 31, 2026
    v5
  5. Minor Site details revised at 1 of 2 sitesv4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 19, 2023 to Jun 27, 2023
    • Site details revised at 2 of 2 sites
    • Study description expanded, about 4 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05919940
Lead Sponsor Technical University of Munich
Collaborators: Fresenius Kabi, University Medicine Greifswald, Berlin Institute of Health, Universitätsklinikum Ulm, Medical University of Vienna
Conditions
(from sponsor)
ICU Acquired Weakness, Muscle Atrophy, Energy Malnutrition Protein, Quality of Life, Morphological and Microscopic Findings, Metabolic Disturbance
Related terms Morphological and Microscopic Findings, Muscular Atrophy, Protein-Energy Malnutrition
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov