Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 7:02 AM
Study NCT ID:
NCT01735435
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2012-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tight Caloric Balance in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2012-11-24', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of postoperative complications', 'timeFrame': 'up to day 14', 'description': 'incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated'}], 'secondaryOutcomes': [{'measure': 'Energy balance', 'timeFrame': 'prior to surgery and up to 14 day', 'description': 'energy intake and calculated energy balance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['geriatric patients', 'nutritional support'], 'conditions': ['Nutrition Assessment']}, 'descriptionModule': {'briefSummary': 'The aim of this study to assess the impact of nutritional support guided by repeated measurements of REE in geriatric patients following surgery for hip fractures.\n\nOur hypothesis is that tight caloric control will reduce the risk of significant postoperative complications in geriatric patients following surgery for hip fractures.\n\nStudy Design :Prospective, Single center, Randomized, Unblinded study. Study Population:geriatric patients following surgery for hip fractures.', 'detailedDescription': 'The primary outcome:\n\npresence of postoperative complications,hospital length of stay.\n\nSecondary outcomes:\n\nenergy intake and calculated energy balance\n\nStudy Procedure:\n\neligible patients will be randomly assigned to 2 groups: the tight calorie (intervention)group and the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients older than 65 years who were admitted to the unit following hip fracture within 48 hours of the injury and in whom orthopedic surgery was considered the treatment of choice.\n\nExclusion Criteria:\n\nPatients were excluded if they presented to hospital \\> 48 hours after the injury, were receiving steroids and/or immunosuppression therapy; in the presence of active oncologic disease, multiple fractures, diagnosed dementia or in the event that patients required supplemental nasal oxygen which precludes the measurement of resting energy expenditure.'}, 'identificationModule': {'nctId': 'NCT01735435', 'acronym': 'TICACOSiGP', 'briefTitle': 'Tight Caloric Balance in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Tight Caloric Balance in Geriatric Patients After Hip Fracture.', 'orgStudyIdInfo': {'id': '5744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 2 (Control group)', 'description': 'Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.'}, {'type': 'EXPERIMENTAL', 'label': 'Group 1 (Indirect Calorimetry)', 'description': 'Group 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.', 'interventionNames': ['Other: Indirect Calorimetry']}], 'interventions': [{'name': 'Indirect Calorimetry', 'type': 'OTHER', 'otherNames': ['Energy intake according to REE measurements(nutrition according to the individual energy requirements)'], 'description': 'The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.\n\nIC measurements:after a fasting period of at least 6 hours at three time periods : on admission to the study,between 24-48 hours following surgery and on the 7th day of the study.Measurements were performed by an experienced nurse or dietician,the device was automatically calibrated before each measurement and the REE was recorded after 15 minutes.', 'armGroupLabels': ['Group 1 (Indirect Calorimetry)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'RabinMC', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Pierre Singer, Professor,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RabinMC,Beilinson Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Pierre Singer, MD', 'investigatorFullName': 'Pierre singer', 'investigatorAffiliation': 'Rabin Medical Center'}}}}