Muscle wasting and whey protein-enriched nutrition
Conditions
Interventions
Group 1 (the intervention group) will receive, in addition to a standardized
exercise training program and standard enteral nutrition with a protein intake
of 1.0 g/kg/day, a whey protein supplement
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Admitted to the intensive care unit; Age >= 18 years; On mechanical ventilation and expected to be mechanically ventilated for more than 72 hours after initiation of study; Expected to tolerate enteral nutrition and to require enteral nutrition for more than 72 hours; SOFA score >= 6 on admission day; Written informed consent of patient or legal representative.
Exclusion criteria
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; 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, PT >1.4 , Thrombocytes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our primary endpoint will be In vitro loss of skeletal muscle function measured by contractility of individual muscle fibers between day 1-3 after inclusion and 7 days later (day 8-10). Contractility parameters include maximal force, calcium sensitivity of force, and myosin-actin kinetics. Long- (between day 1-3 and day 28) and short term (between day 1-3 and day 8-10) loss of in vivo muscle mass will be assessed with bio-impedance analysis, B-mode ultrasound of the m. quadriceps femoris and diaphragm thickness. Clinical (in vivo) muscle function on day 1 (if feasible), 8-10 and 28 will be measured with Medical Research Council (MRC) sum score, handgrip strength,Maximal inspiratory and expiratory force and Short Physical Performance Battery test. Also markers of systemic inflammation, change in muscle morphology, day-28 clinical outcome and quality of life, and safety will be investigated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine whether leucine-rich high protein intake, in addition to standardized exercise and standard enteral nutrition: - Preserves short- and long-term in vivo muscle function and mass, and clinical outcomes and quality of life in critically ill patients - Increases muscle protein synthesis and attenuates activation of the Ubiquitin-Proteasome pathway in critically ill patients. 2) To determine the relation between clinical markers for muscle function (e.g. MRC) and in vitro muscle function. | — |
Countries
Netherlands
Outcome results
None listed