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

Completed

Conditions: Muscle wasting and whey protein-enriched nutrition
10028302

Registration Number: NL-OMON44160

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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 <100).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary endpoint will be In vitro loss of skeletal muscle function measured<br /><br>by contractility of individual muscle fibers between day 1-3 after inclusion<br /><br>and 7 days later (day 8-10). Contractility parameters include maximal force,<br /><br>calcium sensitivity of force, and myosin-actin kinetics.<br /><br>Long- (between day 1-3 and day 28) and short term (between day 1-3 and day<br /><br>8-10) loss of in vivo muscle mass will be assessed with bio-impedance analysis,<br /><br>B-mode ultrasound of the m. quadriceps femoris and diaphragm thickness.<br /><br>Clinical (in vivo) muscle function on day 1 (if feasible), 8-10 and 28 will be<br /><br>measured with Medical Research Council (MRC) sum score, handgrip<br /><br>strength,Maximal inspiratory and expiratory force and Short Physical<br /><br>Performance Battery test. Also markers of systemic inflammation, change in<br /><br>muscle morphology, day-28 clinical outcome and quality of life, and safety will<br /><br>be investigated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To determine whether leucine-rich high protein intake, in addition to<br /><br>standardized exercise and standard enteral nutrition:<br /><br>- Preserves short- and long-term in vivo muscle function and mass, and clinical<br /><br>outcomes and quality of life in critically ill patients<br /><br>- Increases muscle protein synthesis and attenuates activation of the<br /><br>Ubiquitin-Proteasome pathway in critically ill patients.<br /><br>2) To determine the relation between clinical markers for muscle function (e.g.<br /><br>MRC) and in vitro muscle function.</p><br>