Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-31 @ 6:03 AM
Study NCT ID:
NCT06373068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Resuscitation Orders and Mortality in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016414', 'term': 'Resuscitation Orders'}], 'ancestors': [{'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013727', 'term': 'Terminal Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D007603', 'term': 'Jurisprudence'}, {'id': 'D012926', 'term': 'Social Control, Formal'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '365 days', 'description': 'Hazard ratio of death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resuscitation orders'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients admitted to the intensive care unit during 2023 and 2024', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to ICU\n\nExclusion Criteria:\n\n* Second or subsequent admission to ICU during the study period.'}, 'identificationModule': {'nctId': 'NCT06373068', 'briefTitle': 'Association Between Resuscitation Orders and Mortality in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Retrospective Study of the Association of Different Levels of Resuscitation Orders and Mortality in ICU Patients.', 'orgStudyIdInfo': {'id': 'Resuscitation Orders ICU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full code', 'description': 'Patients without any restrictions on the types of treatments available, such as cardiopulmonary resuscitation, intubation, various life support measures, surgery, etc., if indicated.', 'interventionNames': ['Other: Resuscitation orders']}, {'label': 'Simple Do-Not-Attempt-Resuscitation', 'description': 'The only treatment limitation in patient care is cardiopulmonary resuscitation in case of a cardiac arrest. All other indicated devices or treatments may still be utilized.', 'interventionNames': ['Other: Resuscitation orders']}, {'label': 'Do not attempt resuscitation with limited scope', 'description': 'The treatment limitation in patient care includes not performing cardiopulmonary resuscitation and also involve additional limitations, typically including various life support measures.', 'interventionNames': ['Other: Resuscitation orders']}], 'interventions': [{'name': 'Resuscitation orders', 'type': 'OTHER', 'description': 'Resuscitation orders, commonly referred to as Code Status, communicate to the healthcare team the specific medical interventions that patients will receive while hospitalised. These orders are issued by a doctor and require confirmation by at least one other licensed medical professional', 'armGroupLabels': ['Do not attempt resuscitation with limited scope', 'Full code', 'Simple Do-Not-Attempt-Resuscitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Sandra Jonmarker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stockholm South General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The privacy of the data is protected under Swedish law, and the original patient data will be stored in a de-identified form for 10 years in accordance with Karolinska Institute regulations. Use of the de-identified data for research purposes beyond those specified in this registration may be considered, but requires additional approval from the Swedish Ethics Committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant in Anaesthesia and Intensive care, Ph D', 'investigatorFullName': 'Sandra Jonmarker', 'investigatorAffiliation': 'Karolinska Institutet'}}}}