Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-16 @ 11:42 AM
Study NCT ID:
NCT02503527
Status:
TERMINATED
Last Update Posted:
2022-03-31
First Post:
2015-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Low Recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2015-07-10', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose variability (within patient standard deviation of blood glucose values per day)', 'timeFrame': 'At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first'}], 'secondaryOutcomes': [{'measure': 'Glucose variability', 'timeFrame': 'Days 2, 4 and 5 of intervention'}, {'measure': 'Time to switch from intravenous to subcutaneous insulin administration', 'timeFrame': 'Days 1-6, daily'}, {'measure': 'Insulin requirements in IU per day', 'timeFrame': 'Days 1 - 6, daily'}, {'measure': 'Blood glucose levels', 'timeFrame': 'Days 1 - 6, daily'}, {'measure': 'HbA1c', 'timeFrame': 'Days 1, 6, 28'}, {'measure': 'Difference between target and given enteral nutrition (Compliance)', 'timeFrame': 'Days 2-6, daily'}, {'measure': 'Cerebral and subcutaneous microdialysis: glucose', 'timeFrame': 'Days 1 - 6, daily'}, {'measure': 'Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio', 'timeFrame': 'Days 1 - 6, daily'}, {'measure': 'Hospital mortality', 'timeFrame': 'Day 28'}, {'measure': 'ICU mortality', 'timeFrame': 'Day 28'}, {'measure': 'ICU length of stay', 'timeFrame': 'Day 28'}, {'measure': 'Days of mechanical ventilation', 'timeFrame': 'Day 28'}, {'measure': 'Non-gastrointestinal complications (AEs) to enteral nutrition and application', 'timeFrame': 'Days 2-6, daily'}, {'measure': 'Gastro-intestinal intolerance (AEs, complications)', 'timeFrame': 'Days 2-6, daily'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Enteral nutrition', 'Tube feeding', 'Diet, carbohydrate-restricted', 'Diabetes', 'Aneurysmal Subarachnoid Hemorrhage', 'Blood glucose', 'Insulin'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5\n* Requiring mechanical ventilation in the ICU at the time of enrolment\n* Enteral nutrition (EN) in the ICU at time of enrolment\n\n * If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay\n * If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment\n* Patients expected to stay in the ICU for at least 5 days following enrolment\n* Age 18 - 75 years\n* Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l)\n* Informed consent according to local regulations for decisionally impaired subjects\n\nExclusion Criteria:\n\n* Patients with septic shock at time of enrolment\n* Participation in a clinical trial with any investigational product within 4 weeks before study\n* Patients requiring a fibre free diet\n* Total or supplementary parenteral nutrition (\\> 20% of total calories)\n* Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia\n* Gastrectomy\n* Postpyloric nutrition\n* Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea)\n* Known severe heart failure (NYHA class 4)\n* Liver insufficiency / failure (male: ALAT \\> 150 U/l; female: ALAT \\> 120 U/l)\n* Acute kidney failure (blood creatinine \\> 2.5 mg/dl)\n* Body Mass Index \\< 18 or \\> 35 kg/m²\n* Known or suspicion of drug abuse\n* Pregnant or breast feeding women\n* Patients with diabetes mellitus type I\n\nExclusion After Enrolment (Withdrawal of Subjects)\n\n* Start of PN with more than 20% of total given energy amount/ day\n* Insulin infusion stopped unexpectedly for \\> 12h for non-nutritional reasons\n* Discharge from ICU\n* Intolerable AEs\n* Major protocol violation\n* Withdrawal of informed consent\n* Discontinuation of study treatment for other reasons'}, 'identificationModule': {'nctId': 'NCT02503527', 'briefTitle': 'Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management', 'orgStudyIdInfo': {'id': 'DBHP-001-CEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Diben 1.5 kcal HP', 'description': 'Diben 1.5 kcal HP, Food for Special Medical Purposes (diabetes-specific tube feed)', 'interventionNames': ['Other: Diben 1.5 kcal HP']}, {'type': 'OTHER', 'label': 'Fresubin HP Energy Fibre (1.5 kcal)', 'description': 'Fresubin HP Energy Fibre (1.5 kcal), Food for Special Medical Purposes (standard tube feed)', 'interventionNames': ['Other: Fresubin HP Energy Fibre (1.5 kcal)']}], 'interventions': [{'name': 'Diben 1.5 kcal HP', 'type': 'OTHER', 'description': "Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \\> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).", 'armGroupLabels': ['Diben 1.5 kcal HP']}, {'name': 'Fresubin HP Energy Fibre (1.5 kcal)', 'type': 'OTHER', 'description': "Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) \\> 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).", 'armGroupLabels': ['Fresubin HP Energy Fibre (1.5 kcal)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitätsklinikum Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Ronny Beer, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck, Department of Neurology, Neurocritical Care Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'OE Clinical Trial Center (KKS) Universität Innsbruck', 'class': 'UNKNOWN'}, {'name': 'International Medical Research - Partner GmbH', 'class': 'OTHER'}, {'name': 'dsh statistical services GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}