Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT03249051
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2017-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002153', 'term': 'Calorimetry, Indirect'}], 'ancestors': [{'id': 'D002151', 'term': 'Calorimetry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2017-06-25', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase angle (PhA)', 'timeFrame': 'PhA was measured between one and 90 days (during ICU stay)', 'description': 'The primary endpoint is the change of the phase angle during the stay in the intensive care unit (ICU). A mean difference of 5% is considered as relevant.'}], 'secondaryOutcomes': [{'measure': 'Nitrogen Balance', 'timeFrame': 'Nitrogen Balance was measured between one and 90 days (during ICU stay)', 'description': 'Difference between intervention and control group between hospital admission and discharge.'}, {'measure': 'Extracellular to body cell mass ratio (ECM/BCM - Ratio)', 'timeFrame': 'ECM/BCM-Ratio was measured between one and 90 days (during ICU stay)', 'description': 'Difference between intervention and control group between hospital admission and discharge.'}, {'measure': 'Length of hospital stay in days', 'timeFrame': 'Length of hospital stay was measured between one and 180 days', 'description': 'Difference between intervention and control group between hospital admission and discharge.'}, {'measure': 'Length of stay in intensive care unit (ICU) in days', 'timeFrame': 'Length of ICU stay was measured between one and 90 days', 'description': 'Difference between intervention and control group between hospital admission and discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether an individualized determination of energy requirements using indirect calorimetry instead of a formula-based approach leads to an optimized nutritional support and as a consequence to an optimized nutritional status of the critically ill, mechanically ventilated patients measured by the phase angle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* mechanical ventilation\n* an hospital stay of at least three days at the intensive care unit of the University Hospital of Tübingen\n* possibility to perform indirect calorimetry measurements (FiO2 ≤70, PCO2 ≤ 0,5)\n* possibility to perform Bioelectrical Impedance Analysis (BIA)\n* underlying indication for enteral or/and parenteral nutritional support\n* written informed consent from the patient or a legal authorized person\n\nExclusion Criteria:\n\n* cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT03249051', 'acronym': 'ONCA', 'briefTitle': 'Optimization of Nutritional Therapy in Mechanically Ventilated, Critically Ill Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Optimization of Nutritional Therapy by Variation of Methods to Determine Energy Needs in Mechanically Ventilated, Critically Ill Patients.', 'orgStudyIdInfo': {'id': 'Indirect Calorimetry in ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indirect Calorimetry', 'description': 'The energy need is being determined by using indirect calorimetry and if necessary, optimized by parenteral, enteral and additive parenteral nutrition.', 'interventionNames': ['Other: Indirect Calorimetry']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'This group receives nutrition supply according to the hospital routine ("standard care")'}], 'interventions': [{'name': 'Indirect Calorimetry', 'type': 'OTHER', 'description': 'Energy need is being determined using indirect Calorimetry', 'armGroupLabels': ['Indirect Calorimetry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'University of Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Stephan C Bischoff', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hohenheim, 70599 Stuttgart, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}