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

Critically Ill Clinical Trial

— PRESMUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231540
• Other study ID #: 2016.101
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2017
• Last updated: July 26, 2017
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: VU University Medical Center
• Contact: Sandra N Stapel, MD
• Email: s.stapel[@]vumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Dietary Supplement:
• Whey protein supplement
Whey protein supplement to target protein intake of 1.5 g/kg/day

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Nestlé

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in vitro loss of skeletal muscle function	measured by contractility of of individual muscle fibers	day 1-3 and day 8-10
Secondary	loss of muscle function	Medical research council (MRC) sum score,	day 1-3, day 8-10, day 28
Secondary	changes in body composition	Bioelectrical impedance analysis (BIA)	day 1-3, day 8-10, day 28
Secondary	loss of muscle mass	Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires	day 1-3, day 8-10, day 28
Secondary	quality of life	Short form (SF)- 36 questionnaire	3 months