The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)

Study Overview
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Brief Summary
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This study evaluates the effect of whey protein enriched enteral nutrition in addition to exercise training on the preservation of muscle function in critically ill patients. One half of patients receive whey protein enriched enteral nutrition with a protein intake of 1.5 g/kg/day and the other half of patients receive standard enteral nutrition with a protein intake of 1 g/kg/day.

Detailed Description
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Muscle wasting has an enormous impact on long-term physical performance and quality of life of intensive care survivors. Limitation of muscle wasting might therefore improve physical performance and quality of life. Data on high protein nutritional intake in addition to a standardized exercise training program to prevent skeletal muscle wasting during critical illness are lacking. Objective: to determine whether early high protein intake, using an enteral whey protein supplement, in addition to a standardized exercise training program and standard enteral nutrition preserves: a) in vitro skeletal muscle function in critically ill patients during the first week of intensive care unit (ICU) admission and b) short- and long-term in vivo muscle function and mass, clinical outcomes and quality of life in critically ill patients. Secondly, to determine whether high protein intake, in addition to standardized exercise and standard enteral nutrition, increases muscle protein synthesis and attenuates activation of the Ubiquitin-Proteasome pathway in critically ill patients.

Official Title
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Effect of Whey Protein-enriched Enteral Nutrition in Addition to Standardized Exercise Training on the PREServation of MUScle Function in Critically Ill Patients: A Randomized Controlled Trial

Conditions
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Critically Ill

Intervention / Treatment
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* Dietary Supplement: Whey protein supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the intensive care Mechanically ventilated Expected duration of ventilation of 72 hours Expected to tolerate and require enteral nutrition for more than 72 hours Sequential organ failure assessment (SOFA)-score>6 on admission day Written informed consent of patient or legal representative Exclusion Criteria: Contra-indication to enteral nutrition Short bowel syndrome Child C liver cirrhosis or acute liver failure Dialysis dependency Requiring other specific enteral nutrition for medical reason Body mass index (BMI) > 35 kg/m2 Extensive treatment limitations Disseminated malignancy Haematological malignancy Primary neuromuscular pathology Chronic use of corticosteroids for > 7 days before ICU admission Contra-indication for muscle biopsy (need for uninterrupted systemic anticoagulation, prothrombin time >1.4 , Thrombocytes <100).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training | Dietary Supplement: Whey protein supplement<br>* Whey protein supplement to target protein intake of 1.5 g/kg/day<br>* Other names: Beneprotein Nestle;|
| No Intervention: control group<br>standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in vitro loss of skeletal muscle function | measured by contractility of of individual muscle fibers | day 1-3 and day 8-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loss of muscle function | Medical research council (MRC) sum score, | day 1-3, day 8-10, day 28 | 
| changes in body composition | Bioelectrical impedance analysis (BIA) | day 1-3, day 8-10, day 28 | 
| loss of muscle mass | Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires | day 1-3, day 8-10, day 28 | 
| quality of life | Short form (SF)- 36 questionnaire | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, nutrition, whey protein, mechanical ventilation, muscle function