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Not Yet Recruiting NCT05627167

Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial

Conditions: Enteral Nutrition

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 318
Sponsor: Centre Hospitalier le Mans

Location: France

Summary

Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and DNA repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.

Eligibility Criteria

Inclusion Criteria:Patient aged 18 years and over admitted to intensive careOn invasive mechanical ventilation for less than 24 hoursWith an indication for exclusive enteral feeding by naso- or oro-gastric tubeWith an expected remaining duration of mechanical ventilation > 72 hoursExclusion Criteria:Enteral feeding via tube already startedParenteral nutrition in progress or deemed necessary by the practitionerActive digestive haemorrhage as evidenced by fibroscopy or with need for transfusionDigestive surgery less than one month oldHistory of mesenteric ischaemiaHistory of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndromePregnant, lactating or parturient womanBody mass index < 18 kg/m2Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)Lack of social security coverageLack of consent or emergency procedure formPatient participating in another randomised clinical research study on feeding of resuscitation patients

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Source: ClinicalTrials.gov (NCT05627167). StuddyBuddy aggregates publicly available trial information.