Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-01 @ 7:43 PM
Study NCT ID:
NCT06770751
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Involvement in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sedative dose', 'timeFrame': 'Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.', 'description': 'It is the average daily dose of sedative drugs used by a patient. It will be calculated for each sedative drug. It will be calculated by dividing all doses taken by the number of days of hospitalization.'}], 'secondaryOutcomes': [{'measure': 'Delirium', 'timeFrame': 'Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.', 'description': 'Each patient will be assessed for delirium every day during their hospitalization. CAM-ICU scoring will be used for assessment. The average number of delirium days for each patient will be found by dividing the number of days they were in delirium by the total number of days they were in hospital.'}, {'measure': 'Ventilatory days', 'timeFrame': 'Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.', 'description': 'For each patient, the number of days they are on a ventilator will be calculated as a percentage of their length of stay. For each patient, the days they receive invasive ventilation will be divided by the number of days they are treated in the intensive care unit to calculate the percentage.'}, {'measure': 'Stay in intensive care unit', 'timeFrame': 'Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.', 'description': 'The length of time each patient stays in intensive care will be recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intensive care patients', 'relatives', 'Delirium in the intensive care unit', 'Sedatives'], 'conditions': ['Intensive Care Patients', 'Relatives', 'Delirium in the Intensive Care Unit', 'Sedatives', 'Family']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.\n\nThe main question it aimed to answer was:\n\nDoes spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients in a tertiary intensive care unit of a university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 and over.\n* Patients with at least one family member actively involved in the care process in the ICU.\n\nExclusion Criteria:\n\n* Patients with pre-existing cognitive impairment or dementia.\n* Patients with severe traumatic brain injury.\n* Patients with an expected mortality in the ICU of more than 80%.\n* Absence of family members for patients admitted to the ICU.'}, 'identificationModule': {'nctId': 'NCT06770751', 'briefTitle': 'Family Involvement in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Family Involvement in the Intensive Care Unit: a Prospective Cohort Study Exploring Its Effects on Sedation Dosages, Delirium, Ventilator-Free Days, and Length of Stay.', 'orgStudyIdInfo': {'id': '2024/231'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short involvement of family', 'description': 'A group where relatives spend up to 2 hours with patients and are involved in their care.'}, {'label': 'Long involvement of family', 'description': 'A group where relatives spend more than 2 hours with patients and are involved in their care.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34153', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Oguzhan Kayhan', 'role': 'CONTACT', 'email': 'oguzhan.kayhan@iuc.edu.tr', 'phone': '0090 212 414 3000', 'phoneExt': '63943'}], 'facility': 'Cerrahpaşa Medical Faculty', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Oguzhan Kayhan', 'role': 'CONTACT', 'email': 'oguzhan.kayhan@iuc.edu.tr', 'phone': '0090 212 414 3000', 'phoneExt': '63943'}], 'overallOfficials': [{'name': 'Oktay Demirkiran, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty'}, {'name': 'Oguzhan Kayhan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Ethics committee approval was not obtained for sharing patient data with an international database.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Lecturer', 'investigatorFullName': 'Oguzhan Kayhan', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}