Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-05-23 @ 10:01 AM
Study NCT ID:
NCT04080557
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2019-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000094682', 'term': 'Endovascular Aneurysm Repair'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D019917', 'term': 'Blood Vessel Prosthesis Implantation'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Data on re-interventions, readmissions and survival were collected until February 2019.', 'description': 'Length of hospital stay in days'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Data on re-interventions, readmissions and survival were collected until February 2019.', 'description': 'Length of ICU stay in days'}, {'measure': 'Reoperations', 'timeFrame': 'Data on re-interventions, readmissions and survival were collected until February 2019.', 'description': 'Reoperations within 30 days after surgery'}, {'measure': 'Complications', 'timeFrame': 'Data on re-interventions, readmissions and survival were collected until February 2019.', 'description': 'Complications within 30 days after surgery'}, {'measure': 'Discharge to a nursing home', 'timeFrame': 'Data on re-interventions, readmissions and survival were collected until February 2019.', 'description': 'Discharge to a nursing home'}], 'primaryOutcomes': [{'measure': 'the incidence of delirium', 'timeFrame': 'between january 2013 and december 2018', 'description': 'The incidence of delirium on the ICU and on the ward'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '6 months and 12 months', 'description': 'mortality divided by ICU delirium and ward delirium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['delirium', 'intensive care unit', 'surgical ward', 'abdominal aortic aneurysm surgery'], 'conditions': ['Delirium', 'AAA', 'Intensive Care Unit Delirium', 'Surgery--Complications', 'Surgery', 'Aortic Aneurysm, Abdominal']}, 'descriptionModule': {'briefSummary': 'The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.\n\nDelirium is a frequent complication in patients who underwent open AAA surgery. This study demonstrated that patients on the surgical ward remain at risk for developing a delirium after ICU dismissal. Physicians should therefore maintain a high level of awareness for delirium in AAA patients who return to the surgical ward after ICU dismissal. This simultaneously emphasises the necessity of delirium preventive measures and early recognition on the surgical ward in order to improve clinical outcomes.', 'detailedDescription': 'The incidence of delirium following open abdominal aortic aneurysm (AAA) surgery is significant, with incidence rates ranging from 12 to 33%. The occurrence of delirium on the surgical ward after intensive care unit (ICU) dismissal in AAA patients remains unclear. Differences in outcomes between a delirium on the ICU and a delirium on the surgical ward have not been previously investigated.\n\nAn observational cohort study was conducted that included all patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018. The diagnosis of delirium was verified by a psychiatrist or geriatrician using the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria. Cox proportional hazards regression analysis was used to analyse 6- and 12-months survival rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 135 patients were included in the study. Of these, 72 were treated for a ruptured abdominal aortic aneurysm and 63 were treated electively with open aortic repair.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.\n\nExclusion Criteria:\n\n* Patients that did not survive surgery\n* Patients that did not go to the intensive care unit postoperatively.'}, 'identificationModule': {'nctId': 'NCT04080557', 'briefTitle': 'Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal', 'organization': {'class': 'OTHER', 'fullName': 'Amphia Hospital'}, 'officialTitle': 'Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal', 'orgStudyIdInfo': {'id': '305213JR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AAA patients that went to the ICU postoperatively', 'description': 'An retrospective cohort study was conducted that included all patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.', 'interventionNames': ['Other: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'OTHER', 'otherNames': ['Open abdominal aortic repair', 'Endovascular aortic repair'], 'description': 'All patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.', 'armGroupLabels': ['AAA patients that went to the ICU postoperatively']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4818CK', 'city': 'Breda', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Amphia hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}], 'overallOfficials': [{'name': 'Lijckle van der Laan, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amphia hospital Breda, the Netherlands'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amphia Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Joost Roijers', 'investigatorAffiliation': 'Amphia Hospital'}}}}