Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT06178835
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EPO for Postop Delirium in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delirium', 'timeFrame': '2 days post surgery, 5 days post surgery', 'description': 'Development of postoperative delirium determined by validated evaluation tests.'}], 'secondaryOutcomes': [{'measure': 'Inflammatory biomarker', 'timeFrame': 'before surgery, after surgery, 3 days post surgery day 3', 'description': 'Preoperative and postoperative comparison of inflammatory biomarkers (IL-1, IL-6, TNF-a)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Delirium']}, 'referencesModule': {'references': [{'pmid': '39548414', 'type': 'DERIVED', 'citation': 'Kim EJ, Park KK, Choi SY, Ju HM, Kim TL, Kim J, Kim SY, Koo BN. Erythropoietin for the prevention of postoperative neurocognitive disorder in older adult patients undergoing total joint arthroplasty: a randomized controlled study. BMC Anesthesiol. 2024 Nov 15;24(1):418. doi: 10.1186/s12871-024-02770-9.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65 years and older\n* Patients scheduled for elective total knee arthroplasty, total hip arthroplasty\n\nExclusion Criteria:\n\n* Unable to communicate\n* Cognitive impairment\n* Unable to pre-screen delirium due to underlying central nervous system disease\n* History of hypersensitivity related to erythropoietin and other anesthesia-related drugs\n* History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease\n* Uncontrolled high blood pressure\n* Within one month of starting anti-hypertensive medication'}, 'identificationModule': {'nctId': 'NCT06178835', 'briefTitle': 'EPO for Postop Delirium in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study', 'orgStudyIdInfo': {'id': '4-2017-0694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythropoietin', 'description': '500 IU/kg of EPO given intramuscularly 3 times for each patient', 'interventionNames': ['Drug: Erythropoietin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Same amount of normal saline given intramuscularly 3 times for each patient', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Erythropoietin', 'type': 'DRUG', 'description': '500 IU/kg of erythropoietin is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.', 'armGroupLabels': ['Erythropoietin']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'The same amount of normal saline is given 3 times for each patient: the day before surgery, start of surgery and on postoperative day 1.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bon-Nyeo Koo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Pain medicine, Severance Hospital, Seoul, South Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}