Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT03682393
Status:
WITHDRAWN
Last Update Posted:
2022-04-07
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Corticosteroid Treatment After Mitral Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The study is double blinded, neither the patients or investigators or nurses managing the drugs do not know whether the patient receives placebo (isotonic saline) or active drug (corticosteroid). In case of emergency the codes can be cracked.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'half of the recruited patients will receive intravenous corticosteroid and the other half will receive intravenous isotonic saline as placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'the study never started', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'atrial fibrillation', 'timeFrame': 'three days after mitral valve surgery', 'description': 'Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative', 'atrial fibrillation', 'post cardiac surgery', 'corticosteroid'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.', 'detailedDescription': 'Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* open mitral valve surgery\n* patients agrees to participate in the study\n* adult (minimum 18 years of age)\n\nExclusion Criteria:\n\n* atrial fibrillation onset before first postoperative morning\n* prolonged intensive care unit stay (patient needs to stay in intensive care unit after first postoperative day)\n* patient is underaged, does not want to participate or can not make the decision by himself or herself because of ie memory disability\n* diabetes mellitus requiring insulin treatment and with recent hypo- or hyperglycemias which required hospital treatment\n* systemic mucous infections\n* known allergy or oversensitivity to hydrocortisone\n* Cushing syndrome\n* history of psychosis\n* history of ulcus or active ulcus\n* chronic atrial fibrillation or atrial flutter\n* corticosteroid or immunosuppressive treatment in use for any reason\n* active tuberculosis infection\n* severe renal impairment (serum creatinine 200 umol/l or over)\n* history of deep or superficial venous trombosis\n* Herpes simplex -ceratitis'}, 'identificationModule': {'nctId': 'NCT03682393', 'acronym': 'MitralPOCS', 'briefTitle': 'Post-operative Corticosteroid Treatment After Mitral Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Does Post-operative Corticosteroid Treatment Prevent New-onset Atrial Fibrillation After Mitral Valve Surgery?', 'orgStudyIdInfo': {'id': 'KUH5101126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrocortisone', 'description': '100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset', 'interventionNames': ['Drug: Hydrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebos', 'description': '100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'otherNames': ['corticosteroid'], 'description': '100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset', 'armGroupLabels': ['Hydrocortisone']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['placebo, saline'], 'description': '100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset', 'armGroupLabels': ['Placebos']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70029', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Jari Halonen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'general surgery attending, clinical teacher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD are not to be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}