NCT06330610 Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit
| NCT ID | NCT06330610 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Intermittent Fasting |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2027-10-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 174 participants in total. It began in 2024-07-09 with a primary completion date of 2027-10-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06330610 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intermittent Fasting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06330610 currently recruiting?
Yes, NCT06330610 is actively recruiting participants. Contact the research team at fabienne.tamion@chu-rouen.fr for enrollment information.
Where is the NCT06330610 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT06330610 clinical trial?
NCT06330610 is sponsored by University Hospital, Rouen. The trial plans to enroll 174 participants.