Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-02 @ 9:12 AM
Study NCT ID:
NCT05627167
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2022-11-16', 'studyFirstSubmitQcDate': '2022-11-16', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of organ failures', 'timeFrame': 'Day 7', 'description': 'Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups'}], 'secondaryOutcomes': [{'measure': 'Average daily caloric intake', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average daily caloric intake from enteral nutrition'}, {'measure': 'Proportion of patients achieving > 80% of their recommended caloric intake at D7', 'timeFrame': 'Day 7'}, {'measure': 'Average daily protein intake', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average daily protein intake in grams'}, {'measure': 'Vomiting', 'timeFrame': 'Day 1 to Day 10', 'description': 'Number of days with vomiting (passage of nutrition into the mouth or the endoctracheal tube)'}, {'measure': 'Diarrhea', 'timeFrame': 'Day 1 to Day 10', 'description': 'Number of days with more than four episodes of liquid stools'}, {'measure': 'Constipation', 'timeFrame': 'Day 1 to Day 10', 'description': 'Number of stool free days'}, {'measure': 'Intestinal ischemia', 'timeFrame': 'Day 1 to Day 10', 'description': 'Number of patients suffering an episode of intestinal ischemia'}, {'measure': 'Ventilator acquired pneumonia', 'timeFrame': 'Day 1 to Day 10', 'description': 'Number of episodes of ventilator acquired pneumonias'}, {'measure': 'Insulin consumption', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average insulin consumption expressed in international units per kg per day'}, {'measure': 'Lactatemia', 'timeFrame': 'Day 1 to Day 7', 'description': 'Mean lactatemia measured before the start of a new feeding cycle'}, {'measure': 'Hypoglycemia', 'timeFrame': 'Day 1 to Day 7', 'description': 'Number of days with at least one capillary blood glucose \\< 0.6 g/L'}, {'measure': 'Ketonemia', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average capillary ketonemia measured in the morning before the start of a new feeding cycle'}, {'measure': 'Bilirubin', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average total plasma bilirubin levels measured in the morning before the start of a new feeding cycle'}, {'measure': 'Urea', 'timeFrame': 'Day 1 to Day 7', 'description': 'Average plasma urea levels measured in the morning before the start of a new feeding cycle'}, {'measure': 'Mortality', 'timeFrame': 'At Day 28', 'description': 'Whether patient is alive or dead'}, {'measure': 'Days without mechanical ventilation', 'timeFrame': 'Day 1 to Day 28', 'description': 'Number of days without mechanical ventilation at D28'}, {'measure': 'Days intubated', 'timeFrame': 'Day 1 to Day 28', 'description': 'Number of days during the ICU stay where the patient received invasive mechanical ventilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive Care', 'Enteral nutrition', 'Organ Failure'], 'conditions': ['Enteral Nutrition']}, 'referencesModule': {'references': [{'pmid': '38286683', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHowever, 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.\n\nInvestigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years and over admitted to intensive care\n* On invasive mechanical ventilation for less than 24 hours\n* With an indication for exclusive enteral feeding by naso- or oro-gastric tube\n* With an expected remaining duration of mechanical ventilation \\> 72 hours\n\nExclusion Criteria:\n\n* Enteral feeding via tube already started\n* Parenteral nutrition in progress or deemed necessary by the practitioner\n* Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion\n* Digestive surgery less than one month old\n* History of mesenteric ischaemia\n* History of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndrome\n* Pregnant, lactating or parturient woman\n* Body mass index \\< 18 kg/m2\n* Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)\n* Lack of social security coverage\n* Lack of consent or emergency procedure form\n* Patient participating in another randomised clinical research study on feeding of resuscitation patients'}, 'identificationModule': {'nctId': 'NCT05627167', 'acronym': 'DC-SCENIC', 'briefTitle': 'Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier le Mans'}, 'officialTitle': 'Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CHM-2022/S03/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daytime Cyclic enteral nutrition', 'description': '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', 'interventionNames': ['Other: day time cyclic nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous enteral nutrition', 'description': 'Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube', 'interventionNames': ['Other: continuous nutrition']}], 'interventions': [{'name': 'day time cyclic nutrition', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Daytime Cyclic enteral nutrition']}, {'name': 'continuous nutrition', 'type': 'OTHER', 'description': 'Isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube', 'armGroupLabels': ['Continuous enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Centre Hospitalier Du Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonnable request from the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier le Mans', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}