Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-09 @ 1:35 PM
Study NCT ID:
NCT06483958
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burden of symptoms present in the last 24 hours prior to death (or end of follow-up).', 'timeFrame': 'From recruitment until death or day 5 of follow up', 'description': 'The percentage of patients with at least one episode of pain, dyspnea, agitation, or anxiety'}], 'secondaryOutcomes': [{'measure': 'Family satisfaction', 'timeFrame': 'Up to 4 week after death or hospital discharge', 'description': 'Family satisfaction in relatives of adult patients at high risk of death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End of Life Care', 'Critical Illness', 'Palliative Care']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the effectiveness of a palliative care protocol in improving the quality of care of adult patients at high risk of dying hospitalized in the critical care unit.\n\nAssessing symptom burden (dyspnea, pain and/or anxiety/agitation) until death or day 5 (whichever comes first)\n\nResearchers will compare the impact of the palliative care protocol with standard care to see if it improves the quality of care.\n\nParticipants will:\n\n1. Symptom management.\n2. Respect for the autonomy of the patient and his/her family environment.\n3. Respectful management of clinical information.\n4. Provision of holistic care and support.', 'detailedDescription': 'We designed a stepped wedge cluster randomized trial The study is implementation in 5 Chilean hospitals, admitting 248 patients.\n\nPre-intervention (control): The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.\n\nPost-intervention: Palliative care protocol to improve the quality of care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and older\n* Hospitalization in critical care unit for more than 48 hrs.\n* Medical indication of therapeutic effort limitation, defined as: a) Non-initiation or withdrawal of life support therapies: invasive mechanical ventilation, vasoactive drugs, cardiopulmonary resuscitation, renal replacement therapy.\n\nExclusion Criteria:\n\n* Severe communication disorder and cultural language limitation (language other than Spanish).\n* Absence of legal representative and/or caregiver.\n* Brain dead patient.'}, 'identificationModule': {'nctId': 'NCT06483958', 'briefTitle': 'Palliative Care Protocol for Adult Patients Hospitalized in Critical Care Units.', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Palliative Care Protocol for Adult Patients at High Risk of Death in Critical Care Units: A Multicentric Stepped Wedge Cluster Randomised Trial', 'orgStudyIdInfo': {'id': 'OAIC 1315/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Palliative care protocol', 'interventionNames': ['Behavioral: palliative care protocol']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'None intervention'}], 'interventions': [{'name': 'palliative care protocol', 'type': 'BEHAVIORAL', 'description': '1. Symptom management\n2. Respect for patient and family autonomy.\n3. Respectful management of clinical information.\n4. Provision of holistic care and support.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380420', 'city': 'Santiago', 'state': 'Me', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Verónica Rojas, Msc', 'role': 'CONTACT', 'email': 'verorojas@uchile.cl'}, {'name': 'A Palma, Msc', 'role': 'CONTACT', 'email': 'apalmabehnke@gmail.com'}], 'facility': 'Verónica Rojas', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Verónica Rojas, Msc', 'role': 'CONTACT', 'email': 'verorojas@uchile.cl', 'phone': '+56976488006'}, {'name': 'Alejandra Palma, MD', 'role': 'CONTACT', 'email': 'apalmabehnke@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}