Clinical trial NCT03231540: The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill
Keywords: Critical care
nutrition
whey protein
mechanical ventilation
muscle function
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2017-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: in vitro loss of skeletal muscle function
timeFrame: day 1-3 and day 8-10
Secondary outcomes:
measure: loss of muscle function
timeFrame: day 1-3, day 8-10, day 28
measure: changes in body composition
timeFrame: day 1-3, day 8-10, day 28
measure: loss of muscle mass
timeFrame: day 1-3, day 8-10, day 28
measure: quality of life
timeFrame: 3 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Sandra N Stapel, MD
role: PRINCIPAL_INVESTIGATOR
References: