Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
- Conditions
- Enteral Nutrition
- Interventions
- Other: day time cyclic nutritionOther: continuous nutrition
- Registration Number
- NCT05627167
- Lead Sponsor
- Centre Hospitalier le Mans
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daytime Cyclic enteral nutrition day time cyclic 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 Continuous enteral nutrition continuous nutrition Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube
- Primary Outcome Measures
Name Time Method Change of organ failures Day 7 Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups
- Secondary Outcome Measures
Name Time Method Mortality At Day 28 Whether patient is alive or dead
Days intubated Day 1 to Day 28 Number of days during the ICU stay where the patient received invasive mechanical ventilation
Average daily caloric intake Day 1 to Day 7 Average daily caloric intake from enteral nutrition
Proportion of patients achieving > 80% of their recommended caloric intake at D7 Day 7 Average daily protein intake Day 1 to Day 7 Average daily protein intake in grams
Vomiting Day 1 to Day 10 Number of days with vomiting (passage of nutrition into the mouth or the endoctracheal tube)
Diarrhea Day 1 to Day 10 Number of days with more than four episodes of liquid stools
Constipation Day 1 to Day 10 Number of stool free days
Intestinal ischemia Day 1 to Day 10 Number of patients suffering an episode of intestinal ischemia
Ventilator acquired pneumonia Day 1 to Day 10 Number of episodes of ventilator acquired pneumonias
Insulin consumption Day 1 to Day 7 Average insulin consumption expressed in international units per kg per day
Hypoglycemia Day 1 to Day 7 Number of days with at least one capillary blood glucose \< 0.6 g/L
Bilirubin Day 1 to Day 7 Average total plasma bilirubin levels measured in the morning before the start of a new feeding cycle
Urea Day 1 to Day 7 Average plasma urea levels measured in the morning before the start of a new feeding cycle
Days without mechanical ventilation Day 1 to Day 28 Number of days without mechanical ventilation at D28
Lactatemia Day 1 to Day 7 Mean lactatemia measured before the start of a new feeding cycle
Ketonemia Day 1 to Day 7 Average capillary ketonemia measured in the morning before the start of a new feeding cycle
Trial Locations
- Locations (3)
CHU Angers
🇫🇷Angers, France
Centre Hospitalier Du Mans
🇫🇷Le Mans, France
CHRU Tours
🇫🇷Tours, France