Skip to main content
OpenTrials
Completed

NCT Number: NCT05627167

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Enteral Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change of organ failures

    Time frame: Day 7

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

Secondary outcomes

  1. Average daily caloric intake

    Time frame: Day 1 to Day 7

    Average daily caloric intake from enteral nutrition

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

    Time frame: Day 7

  3. Average daily protein intake

    Time frame: Day 1 to Day 7

    Average daily protein intake in grams

  4. Vomiting

    Time frame: Day 1 to Day 10

    Number of days with vomiting (passage of nutrition into the mouth or the endoctracheal tube)

  5. Diarrhea

    Time frame: Day 1 to Day 10

    Number of days with more than four episodes of liquid stools

  6. Constipation

    Time frame: Day 1 to Day 10

    Number of stool free days

  7. Intestinal ischemia

    Time frame: Day 1 to Day 10

    Number of patients suffering an episode of intestinal ischemia

  8. Ventilator acquired pneumonia

    Time frame: Day 1 to Day 10

    Number of episodes of ventilator acquired pneumonias

  9. Insulin consumption

    Time frame: Day 1 to Day 7

    Average insulin consumption expressed in international units per kg per day

  10. Lactatemia

    Time frame: Day 1 to Day 7

    Mean lactatemia measured before the start of a new feeding cycle

  11. Hypoglycemia

    Time frame: Day 1 to Day 7

    Number of days with at least one capillary blood glucose < 0.6 g/L

  12. Ketonemia

    Time frame: Day 1 to Day 7

    Average capillary ketonemia measured in the morning before the start of a new feeding cycle

  13. Bilirubin

    Time frame: Day 1 to Day 7

    Average total plasma bilirubin levels measured in the morning before the start of a new feeding cycle

  14. Urea

    Time frame: Day 1 to Day 7

    Average plasma urea levels measured in the morning before the start of a new feeding cycle

  15. Mortality

    Time frame: At Day 28

    Whether patient is alive or dead

  16. Days without mechanical ventilation

    Time frame: Day 1 to Day 28

    Number of days without mechanical ventilation at D28

  17. Days intubated

    Time frame: Day 1 to Day 28

    Number of days during the ICU stay where the patient received invasive mechanical ventilation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: DC-SCENIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.