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

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

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.

Study Overview

• Status: Unknown
• Conditions: Critically Ill
• Intervention / Treatment: Dietary supplement: Whey protein supplement

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • VU Medical Center
    • Contact: Sandra Stapel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training	Dietary supplement: Whey protein supplement; Whey protein supplement to target protein intake of 1.5 g/kg/day; Other Names: Beneprotein Nestle
No Intervention: control group; standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in vitro loss of skeletal muscle function	measured by contractility of of individual muscle fibers	day 1-3 and day 8-10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
loss of muscle function	Medical research council (MRC) sum score,	day 1-3, day 8-10, day 28
changes in body composition	Bioelectrical impedance analysis (BIA)	day 1-3, day 8-10, day 28
loss of muscle mass	Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires	day 1-3, day 8-10, day 28
quality of life	Short form (SF)- 36 questionnaire	3 months

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: Nestlé
• Investigators: Principal Investigator: Sandra N Stapel, MD, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: mechanical ventilation; nutrition; Critical care; whey protein; muscle function
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2016.101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided