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

NCT03231540 | Unknown

• 1 other identifier: 2016.101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

Critical care; nutrition; whey protein; mechanical ventilation; muscle function

Outcome Measures

Primary Outcomes (1)

• in vitro loss of skeletal muscle function

  measured by contractility of of individual muscle fibers

  day 1-3 and day 8-10

Secondary Outcomes (4)

• loss of muscle function

  day 1-3, day 8-10, day 28

• changes in body composition

  day 1-3, day 8-10, day 28

• loss of muscle mass

  day 1-3, day 8-10, day 28

• quality of life

  3 months

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Whey protein supplement DIETARY_SUPPLEMENT

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

Also known as: Beneprotein Nestle

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

VU Medical Center

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra N Stapel, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra N Stapel, MD

CONTACT

s.stapel@vumc.nl

Monique Waard

CONTACT

mc.dewaard@vumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: intensivist

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: July 27, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

NL (1)