Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-09 @ 8:08 AM
Study NCT ID:
NCT03938961
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2019-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic and Nutritional Characteristics of Long-stayer ICU 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-13', 'studyFirstSubmitDate': '2019-04-27', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Decubitus ulcer', 'timeFrame': 'up to 90 days', 'description': 'Appearance of decubitus ulcer during ICU stay'}], 'primaryOutcomes': [{'measure': 'Vital Status', 'timeFrame': 'up to 90 days', 'description': 'Alive or dead at 90 days after ICU admission'}], 'secondaryOutcomes': [{'measure': 'Force', 'timeFrame': 'up to 90 days', 'description': 'Muscle strength measured by Medical research Council (MRC) score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolism, Energy,Glucose, Protein, Energy deficit'], 'conditions': ['Critically Ill']}, 'referencesModule': {'references': [{'pmid': '28444077', 'type': 'BACKGROUND', 'citation': 'Loss SH, Nunes DSL, Franzosi OS, Salazar GS, Teixeira C, Vieira SRR. Chronic critical illness: are we saving patients or creating victims? Rev Bras Ter Intensiva. 2017 Jan-Mar;29(1):87-95. doi: 10.5935/0103-507X.20170013.'}, {'pmid': '31284633', 'type': 'RESULT', 'citation': 'Viana MV, Pantet O, Bagnoud G, Martinez A, Favre E, Charriere M, Favre D, Eckert P, Berger MM. Metabolic and Nutritional Characteristics of Long-Stay Critically Ill Patients. J Clin Med. 2019 Jul 7;8(7):985. doi: 10.3390/jcm8070985.'}]}, 'descriptionModule': {'briefSummary': 'The intensive care (ICU) patient population has increasing number of very long ICU stays. Long-stayers are usually defined as requiring more than 1 week of mechanical ventilation and of ICU therapy: little is know about their metabolic characteristics and their relation to outcome. The study aims at describing the demographic, nutritional and metabolic aspects of their stay.\n\nAnalysis of 200-250 consecutive patients admitted to the ICU long-stayer program.', 'detailedDescription': 'Data extracted from the computerized ICU system (PDMS): age, Simplified acute physiology score (SAPSII), weight, BMI, Nutrition Risk Score (NRS-2002), daily energy, protein, and glucose intakes, Energy balance, blood glucose (dysglycemia and Glu variability) and lactate, 24hr-insulin (Goal Glu 6-8 mmol/l).\n\nOutcome variables: length of stay (LICU), muscle strength (MRC), vital status at 90 days.\n\nPatients will be followed in detail until ICU discharge and for vital status until day 90 after admission Data will be presented as mean or median, univariate and multivariate analysis will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Critically ill patients who required more than 2 weeks of ICU treatment, and who have entered the ICU's long stayer program", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU length of stay \\> 7 days and enrollment to the long-stayer ICU program\n\nExclusion Criteria:\n\n* Major burns\n* Brain injury\n* Severe neurological condition as primary disease'}, 'identificationModule': {'nctId': 'NCT03938961', 'acronym': 'Nutri-ICU-LS', 'briefTitle': 'Metabolic and Nutritional Characteristics of Long-stayer ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Long-stayer Critically Ill Patients: is the Metabolic and Nutritional Therapy in the ICU Creating the Problem?', 'orgStudyIdInfo': {'id': 'CER2018-02018'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Adult ICU and Burns, University of Lausanne Hospital', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Coded (deidentified) database containing all nutritional, metabolic and laboratory variables'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Mette M Berger', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}