Intermittent versus continuous tube feeding for adults on ventilators with septic shock
Evaluation de l'efficacité du Support Nutritionnel entéral Intermittent Sur la défaillance d'Organes de Patients de réanimation Sous Ventilation assistée ENteral NUTrition - Continue Intermittent
This test tries to see if intermittent (scheduled) tube feeding prevents organ failure better than continuous feeding in adults with septic shock who are on a ventilator in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen, France) |
| Trial ID | NCT06330610 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares intermittent enteral nutrition (scheduled feeding windows) to standard continuous enteral nutrition in adults during the acute phase of septic shock while they are mechanically ventilated. Eligible patients are enrolled within 48 hours of ICU admission, receive nasogastric feeding for about 7 days, and are typically on vasopressors during the intervention. The study measures organ failure-related outcomes and clinical course to determine whether intermittent feeding improves organ function, possibly via effects on protein synthesis, insulin sensitivity, ketogenesis, and autophagy linked to circadian rhythms. The design is motivated by preclinical and observational signals but randomized data in this exact ICU population are limited.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU within 48 hours with septic shock, expected to need invasive mechanical ventilation for at least 48 hours, receiving vasopressors, able to receive nasogastric feeding for 7 days, and able to provide informed consent (or have an authorized surrogate) are eligible.
Not a fit: Patients who are not in acute septic shock, are not mechanically ventilated, cannot tolerate enteral feeding, are pregnant, or have contraindications to intermittent feeding are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, intermittent feeding could reduce the incidence or severity of organ failure and shorten ICU stays for ventilated patients with septic shock.
How similar studies have performed: Some preclinical and observational studies suggest physiologic benefits of intermittent feeding (for example, on protein synthesis and autophagy), but randomized trials in septic shock patients on mechanical ventilation are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rouen, France
- CHU de Rouen — Rouen, France, France (Recruiting)
Study contacts
- Study coordinator: Fabienne TAMION, MD
- Email: fabienne.tamion@chu-rouen.fr
- Phone: +33232888261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.