Critically IllPRESMUSNCT03231540
The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)
A study testing Whey protein supplement in people with Critically Ill, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Whey protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Sandra N Stapel, MD contact
Monique Waard contact
Netherlands1 site, 1 recruiting
- Recruiting
VU Medical Center
Amsterdam
Sandra Stapel, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Critically Ill
- Being tested
- Whey protein supplement
- Keywords
- Critical care, nutrition, whey protein, mechanical ventilation, muscle function
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementDietary supplement
Also called Beneprotein Nestle
Whey protein supplement to target protein intake of 1.5 g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | whey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
in vitro loss of skeletal muscle function
measured by contractility of of individual muscle fibers
Measured: day 1-3 and day 8-10
Secondary outcomes (4)
loss of muscle function
Medical research council (MRC) sum score,
Measured: day 1-3, day 8-10, day 28
changes in body composition
Bioelectrical impedance analysis (BIA)
Measured: day 1-3, day 8-10, day 28
loss of muscle mass
Ultrasound (US) of the quadriceps femoris muscle and diaphragm, questionnaires
Measured: day 1-3, day 8-10, day 28
quality of life
Short form (SF)- 36 questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Sandra Stapel, Amsterdam UMC, location VUmc
- Investigators
- Sandra N Stapel, MD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231540
- Sponsor's protocol ID
- 2016.101
- Acronym
- PRESMUS
- Status last verified
- Jul 2017
- First submitted
- 21 Apr 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03231540
- Acronym / sponsor ID
- PRESMUS / 2016.101
- Conditions
- Critically Ill
- Keywords
- Critical care, nutrition, whey protein, mechanical ventilation, muscle function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: Whey protein supplementwhey protein supplement enriched enteral nutrition, with protein intake of 1.5g/kg/day; in addition to standardized exercise training |
| control group | No intervention | –standard enteral nutrition, with protein intake of 1g/kg/day; in addition to standardized exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementAlso: Beneprotein NestleWhey protein supplement to target protein intake of 1.5 g/kg/day | Dietary supplement | intervention group |
Primary outcome
in vitro loss of skeletal muscle function
Time frame: day 1-3 and day 8-10
measured by contractility of of individual muscle fibers
4 secondary outcomes
loss of muscle function
Time frame: day 1-3, day 8-10, day 28
changes in body composition
Time frame: day 1-3, day 8-10, day 28
loss of muscle mass
Time frame: day 1-3, day 8-10, day 28
quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra N Stapel, MD contact
Monique Waard contact
Sandra N Stapel, MD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement in people with Critically Ill, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra N Stapel, MD (s.stapel@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in vitro loss of skeletal muscle function (time frame: day 1-3 and day 8-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.