Status:
UNKNOWN
The PREServation of MUScle Function in Critically Ill Patients (PRESMUS)
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Société des Produits Nestlé (SPN)
Conditions:
Critically Ill
Eligibility:
All Genders
18+ years
Phase:
NA
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 rec...
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 q...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03231540
Start Date
September 1 2016
End Date
September 1 2018
Last Update
July 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VU Medical Center
Amsterdam, Netherlands