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

Enteral Nutrition Clinical Trial

— DC-SCENIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627167
• Other study ID #: CHM-2022/S03/04
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: November 2023
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

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

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	Centre Hospitalier Du Mans	Le Mans
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

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