Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Continuous enteral nutrition | Active Comparator | Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49000 | France | |||
| Centre Hospitalier Du Mans |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38286683 | Derived | 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. | |
| 38112772 |
Not provided
Not provided
Data will be shared upon reasonnable request from the principal investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 Day 7 |
| 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 |
| Ketonemia | Average capillary ketonemia measured in the morning before the start of a new feeding cycle | 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 |
| Urea | Average plasma urea 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 | At 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 |
| Le Mans |
| 72000 |
| France |
| CHRU Tours | Tours | 37000 | France |
| Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available. |