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

NCT05627167 | Completed

• 1 other identifier: CHM-2022/S03/04
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 3

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 deoxyribonucleic acid (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.

Conditions

Enteral Nutrition

Keywords

Intensive Care; Enteral nutrition; Organ Failure

Outcome Measures

Primary Outcomes (1)

• Change of organ failures

  Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups

  Day 7

Secondary Outcomes (17)

• Average daily caloric intake

  Day 1 to Day 7

• Proportion of patients achieving > 80% of their recommended caloric intake at D7

  Day 7

• Average daily protein intake

  Day 1 to Day 7

• Vomiting

  Day 1 to Day 10

• Diarrhea

  Day 1 to Day 10

Study Arms (2)

Daytime Cyclic enteral nutrition

EXPERIMENTAL

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 enteral nutrition

ACTIVE COMPARATOR

Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube

Other: continuous nutrition

Interventions

day time cyclic nutrition OTHER

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

Daytime Cyclic enteral nutrition

continuous nutrition OTHER

Isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube

Continuous enteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (3)

CHU Angers

Angers, 49000, France

Location

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location

CHRU Tours

Tours, 37000, France

Location

Related Publications (1)

• Callahan JC, Parot-Schinkel E, Asfar P, Ehrmann S, Tirot P, Guitton C. Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients: a study protocol for a randomised controlled trial in three intensive care units in France (DC-SCENIC). BMJ Open. 2024 Jan 29;14(1):e080003. doi: 10.1136/bmjopen-2023-080003.

  PMID: 38286683 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 25, 2022
• Study Start: June 1, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

FR (3)