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

Amsterdam UMC, location VUmc

Status

Unknown

Conditions

Critically Ill

Treatments

Dietary Supplement: Whey protein supplement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03231540

2016.101

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).