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

• Sponsor: Centre Hospitalier le Mans (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05627167
• Collaborator: (none)
• Enrollment: 318
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 33
• Patients Per Site: 106
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Enteral Nutrition	Other: day time cyclic nutrition; Other: continuous nutrition	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 318 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daytime Cyclic enteral nutrition Patients receive continuous isocaloric enteral feeding for 10 hours during the day (e.g. 08:00 to 18:00) via nasal or oro-gastric tube	Other: day time cyclic nutrition; Continuous isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100 mL for 10 hours during the day (e.g. 08:00 to 18:00), via nasal or oro-gastric tube
Active Comparator: Continuous enteral nutrition Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube	Other: continuous nutrition; Isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube

Outcome Measures

Primary Outcome Measures

1. Change of organ failures [Day 7]

   Change is measured by evolution between the Sequential Organ Failure Assessment (SOFA) score (from 0 to 4) at Day7 compared to Day 0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient aged 18 years and over admitted to intensive care

• On invasive mechanical ventilation for less than 24 hours

• With an indication for exclusive enteral feeding by naso- or oro-gastric tube

• With an expected remaining duration of mechanical ventilation > 72 hours

Exclusion Criteria:

• Enteral feeding via tube already started

• Parenteral nutrition in progress or deemed necessary by the practitioner

• Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion

• Digestive surgery less than one month old

• History of mesenteric ischaemia

• History of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndrome

• Pregnant, lactating or parturient woman

• Body mass index < 18 kg/m2

• Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)

• Lack of social security coverage

• Lack of consent or emergency procedure form

• Patient participating in another randomised clinical research study on feeding of resuscitation patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France	49000
2	Centre Hospitalier Du Mans	Le Mans		France	72000
3	CHRU Tours	Tours		France	37000

Sponsors and Collaborators

• Centre Hospitalier le Mans

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier le Mans
• ClinicalTrials.gov Identifier: NCT05627167
• Other Study ID Numbers: CHM-2022/S03/04
• First Posted: Nov 25, 2022
• Last Update Posted: Nov 29, 2022
• Last Verified: Nov 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier le Mans: Intensive Care; Enteral nutrition; Organ Failure

Study Results

No Results Posted as of Nov 29, 2022