Intermittent Fasting, Organ Failure, Multiple, Septic Shock
Conditions
Keywords
Enteral nutrition, Mechanical ventilation, Intermittent fasting, Sepsis shock, Organ failure
Brief summary
This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.
Detailed description
Some pre-clinical and observational studies have suggested that intermittent fasting may have a positive impact on patients in ICU by increasing protein synthesis, sensibility to insulin, cetogenesis, autophagy by respecting the circadian rhythm. This study aims to evaluate the impact on organ failures of an intermittent enteral nutrition versus continuous enteral nutrition in patients at the acute phase of sepsis shock with mechanical ventilation in the ICU.
Interventions
Patients will receive intermittent enteral nutrition, defined as 3 60-minute administrations every 8 hours.
Sponsors
University Hospital, Lille
University Hospital, Caen
Amiens University Hospital
Centre Hospitalier Saint-Philibert, GHICL
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Groupe Hospitalier du Havre
Centre Hospitalier de Dieppe
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient admitted in ICU for less than 48h, with invasive mechanical ventilation predicted for at least 48h, that can undergo nasogastric feeding for 7 days. * Patient under vasopressive drugs * Adult patients (age ≥ 18 years) * Informed person who has read and signed their consent * If the patient is unable to sign their consent (emergency situation), the consent will be signed by a trusted person or a family member, and consent to continue the study will be requested subsequently. * If the patient is unable to sign their consent (emergency situation) and no trusted person is present, the patient may be included in the study. In this case, consent to continue the study will be requested from a trusted person as soon as possible, or from the patient if they are able to understand and sign the consent. * Affiliation to a social security scheme * No current pregnancy: for women of childbearing age, a beta-HCG blood pregnancy test will be performed upon inclusion; for postmenopausal women, a confirmatory diagnosis must be obtained.
Exclusion criteria
* Contraindication to enteral nutrition and/or nasogastric tube insertion: esophageal varices and occlusive syndrome * Artificial enteral nutrition that cannot be initiated within 48 hours of intubation * Enteral nutrition ongoing for more than one hour at the time of inclusion * Need for exclusive or supplemental parenteral nutrition * Moribund patient * Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship * Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. | day-1 (nutrition start) and day-7 | Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of protein intake | from day-1 (nutrition start) to day-7 | evaluation of protein intake (g/kg/day) |
| Measurement of nutritionnal status | day-1 (nutrition start) and day-7 | measurement of weight (kg) |
| Evaluation of the digestive tolerance | from day-1 (nutrition start) to day-7 | Number of vomit (number) |
| Evaluation of the nosocomial infections | from day-1 (nutrition start) to day-7 | Type of infection |
| Adverse events | from day-1 (nutrition start) to day-7 | Number of adverse event |
| evaluation of caloric intake | from day-1 (nutrition start) to day-7 | evaluation of caloric intake (kcal/day) |
| Evaluation of the duration of hospitalisation | day 1 to day 90 | number of days at hospital |
| Evaluation of the intensive care neuromuscular weakness | Up to day 10 | MRC score |
| Evaluation of death | from day 1 to day 90 | Death data collection |
| Evaluation of quality of life | up to day 90 | SF-36 score |
| Evaluation of the metabolic response | day 1, day 4 and day 7 | metabolomics analysis (96 proteins assay) |
Countries
France
Contacts
Primary ContactFabienne TAMION, MD
Backup ContactFlorian VALLIN
Outcome results
None listed