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

Not Applicable

• Conditions: Critically Ill
• Interventions: Dietary Supplement: Whey protein supplement

• Registration Number: NCT03231540
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-04-21
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Study First Posted: 2017-07-27
• Last Update Posted: 2017-07-27
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Whey protein supplement	whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training

Primary Outcome Measures

Name	Time	Method
in vitro loss of skeletal muscle function	day 1-3 and day 8-10	measured by contractility of of individual muscle fibers

Secondary Outcome Measures

Name	Time	Method
quality of life	3 months	Short form (SF)- 36 questionnaire
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

Trial Locations

Locations (1)

VU Medical Center; 🇳🇱 Amsterdam, Netherlands