Critically Ill
Conditions
Keywords
Critical care, nutrition, whey protein, mechanical ventilation, muscle function
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.
Interventions
DIETARY_SUPPLEMENTWhey protein supplement
Whey protein supplement to target protein intake of 1.5 g/kg/day
Sponsors
Société des Produits Nestlé (SPN)
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in vitro loss of skeletal muscle function | day 1-3 and day 8-10 | measured by contractility of of individual muscle fibers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| loss of muscle function | day 1-3, day 8-10, day 28 | Medical research council (MRC) sum score, |
| changes in body composition | day 1-3, day 8-10, day 28 | Bioelectrical impedance analysis (BIA) |
| loss of muscle mass | day 1-3, day 8-10, day 28 | Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires |
| quality of life | 3 months | Short form (SF)- 36 questionnaire |
Countries
Netherlands
Contacts
Primary ContactSandra N Stapel, MD
Backup ContactMonique Waard
Outcome results
None listed