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

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.

Study Overview

• Status: Recruiting
• Conditions: Enteral Nutrition
• Intervention / Treatment: Other: day time cyclic nutrition; Other: continuous nutrition

• Study Type: Interventional
• Enrollment (Estimated): 318
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: +33244710781; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: Jean-Christophe CALLAHAN, MD; Phone Number: +33243434343; Email: jccallahan@ch-lemans.fr

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • Chu Angers
    • Contact: Pierre ASFAR, PHD; Phone Number: 02 41 35 38 15; Email: PiAsfar@chu-angers.fr
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier Du Mans
    • Contact: Christelle JADEAU; Phone Number: +33244710781; Email: cjadeau@ch-lemans.fr
    • Principal Investigator: Jean-Christophe CALLAHAN, MD
  • Tours, France, 37000
    • Recruiting
    • CHRU Tours
    • Contact: Stephan EHRMANN, PHD; Phone Number: 02 47 47 38 55; Email: stephan.ehrmann@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily caloric intake	Average daily caloric intake from enteral nutrition	Day 1 to day 7
Proportion of patients achieving > 80% of their recommended caloric intake at D7		Day 7
Average daily protein intake	Average daily protein intake in grams	Day 1 to day 7
Vomiting	Number of days with vomiting (passage of nutrition into the mouth or the endoctracheal tube)	Day 1 to Day 10
Diarrhea	Number of days with more than four episodes of liquid stools	Day 1 to day 10
Constipation	Number of stool free days	Day 1 to day 10
Intestinal ischemia	Number of patients suffering an episode of intestinal ischemia	Day 1 to day 10
Ventilator acquired pneumonia	Number of episodes of ventilator acquired pneumonias	Day 1 to day 10
Insulin consumption	Average insulin consumption expressed in international units per kg per day	Day 1 to Day7
Lactatemia	Mean lactatemia measured before the start of a new feeding cycle	Day 1 to day 7
Hypoglycemia	Number of days with at least one capillary blood glucose < 0.6 g/L	Day 1 to day 7
Bilirubin	Average total plasma bilirubin levels measured in the morning before the start of a new feeding cycle	Day 1 to day 7
Mortality	Whether patient is alive or dead	AAt day 28
Days without mechanical ventilation	Number of days without mechanical ventilation at D28:	Day 1 to day 28
Days intubated	Number of days during the ICU stay where the patient received invasive mechanical ventilation	Day 1 to day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Intensive Care; Enteral nutrition; Organ Failure
• Other Study ID Numbers: CHM-2022/S03/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared upon reasonnable request from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No