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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention group

whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training

Group Type EXPERIMENTAL

Whey protein supplement

Intervention Type DIETARY_SUPPLEMENT

Whey protein supplement to target protein intake of 1.5 g/kg/day

control group

standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Whey protein supplement

Whey protein supplement to target protein intake of 1.5 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Beneprotein Nestle

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No