Muscle full effect after oral protein: time-dependent concordance and discordance between human muscle protein synthesis and mTORC1 signaling.
Philip J Atherton, Timothy Etheridge, Peter W Watt...
https://pubmed.ncbi.nlm.nih.gov/20844073Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06330610
Evaluation of Intermittent Versus Continuous Enteral Nutrition on Organ Failure in Mechanically Ventilated ICU Patients with Septic Shock
Led by University Hospital, Rouen · Updated on 2025-06-29
174
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Rouen
Lead Sponsor
U
University Hospital, Lille
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates the impact of intermittent enteral nutrition compared to continuous enteral nutrition on preventing organ failures in patients with septic shock who require mechanical ventilation in the intensive care unit (ICU). It explores how intermittent feeding, aligned with the body's natural rhythms, may affect protein production, insulin sensitivity, and other metabolic processes during the acute phase of sepsis. Participants are randomly assigned to one of two groups: one receiving intermittent enteral nutrition with three 60-minute feeding sessions every 8 hours, and the other receiving continuous enteral nutrition. The treatment lasts for at least seven days during their ICU stay. The study is sponsored by the University Hospital, Rouen. During the study, patients' organ function will be monitored using the SOFA score from the start of nutrition to day 7. Researchers will also assess calorie and protein intake, nutritional status, digestive tolerance, infection rates, metabolic responses, neuromuscular weakness, length of hospitalization, survival, and quality of life up to 90 days. Safety and adverse events will be tracked throughout the study period.
CONDITIONS
Brief Title
Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient admitted to ICU for less than 48 hours with invasive mechanical ventilation expected for at least 48 hours
- Patient receiving vasopressor drugs
- Adult aged 18 years or older
- Informed consent signed by patient or trusted person
- Affiliation to a social security scheme
- No current pregnancy: negative pregnancy test for women of childbearing age or confirmed postmenopausal status
You will not qualify if you...
- Contraindications to enteral nutrition or nasogastric tube insertion such as esophageal varices or occlusive syndrome
- Artificial enteral nutrition cannot start within 48 hours of intubation
- Enteral nutrition ongoing for more than one hour at inclusion
- Need for exclusive or supplementary parenteral nutrition
- Moribund patient
- Person deprived of liberty or under judicial protection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 7 days
Participants receive either intermittent enteral nutrition administered as three 60-minute sessions every 8 hours or continuous enteral nutrition while in the ICU with mechanical ventilation.
Daily nutrition administration visits during the 7-day treatment period
Follow-up
Duration - Up to 90 days
Participants are observed for outcomes such as hospitalisation duration, intensive care neuromuscular weakness, survival, and quality of life up to 90 days after treatment start.
Follow-up assessments at various time points up to day 90
Trial Site Locations
Total: 1 location
1
CHU de Rouen
Rouen, France, France, 76031
Actively Recruiting
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Research Team
F
Fabienne TAMION, MD
F
Florian VALLIN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Angela S McNelly, Danielle E Bear, Bronwen A Connolly...
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Javier T Gonzalez, Marlou L Dirks, Andrew M Holwerda...
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Biliana Marcheva, Kathryn M Ramsey, Clara B Peek...
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Humaira Jamshed, Robbie A Beyl, Deborah L Della Manna...
https://pubmed.ncbi.nlm.nih.gov/31151228Feeding Rhythms and the Circadian Regulation of Metabolism.
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https://pubmed.ncbi.nlm.nih.gov/32363197Recovery from critical illness-induced organ failure: the role of autophagy.
Jan Gunst
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Ilse Vanhorebeek, Jan Gunst, Sarah Derde...
https://pubmed.ncbi.nlm.nih.gov/21270330Effect of tolerating macronutrient deficit on the development of intensive-care unit acquired weakness: a subanalysis of the EPaNIC trial.
Greet Hermans, Michael P Casaer, Beatrix Clerckx...
https://pubmed.ncbi.nlm.nih.gov/24461665