Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT06515327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'return of spontaneous circulation', 'timeFrame': '20 minutes after cardiac arrest', 'description': 'patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Arrest, Corticosteroids Use,'], 'conditions': ['Cardiopulmonary Arrest', 'Corticosteroids Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '38254130', 'type': 'BACKGROUND', 'citation': 'Obling LER, Beske RP, Meyer MAS, Grand J, Wiberg S, Mohr T, Damm-Hejmdal A, Forman JL, Frikke-Schmidt R, Folke F, Moller JE, Kjaergaard J, Hassager C. Effect of prehospital high-dose glucocorticoid on hemodynamics in patients resuscitated from out-of-hospital cardiac arrest: a sub-study of the STEROHCA trial. Crit Care. 2024 Jan 22;28(1):28. doi: 10.1186/s13054-024-04808-3.'}, {'pmid': '36225952', 'type': 'BACKGROUND', 'citation': 'Bagate F, Coppens A, Masi P, de Prost N, Carteaux G, Razazi K, Mekontso Dessap A. Cardiac and vascular effects of low-dose steroids during the early phase of septic shock: An echocardiographic study. Front Cardiovasc Med. 2022 Sep 26;9:948231. doi: 10.3389/fcvm.2022.948231. eCollection 2022.'}, {'pmid': '10325953', 'type': 'BACKGROUND', 'citation': 'Ullian ME. The role of corticosteriods in the regulation of vascular tone. Cardiovasc Res. 1999 Jan;41(1):55-64. doi: 10.1016/s0008-6363(98)00230-2. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'We aim to investigate the effects of pre-arrest corticosteroid use for any reason on the time of return of spontaneous circulation in patients experiencing witnessed cardiac arrest, either in-hospital or out-of-hospital. Additionally, we plan to study the effects of corticosteroid use on post-ROSC administration of vasoactive agents, required dosage of vasoactive agents and number of vasoactive agents needed in order to reach targeted blood pressure levels.', 'detailedDescription': "Patients will be collected from Etlik City Hospital Emergency Medicine Department. Patients presenting with witnessed cardiac arrest, either in-hospital or out-of-hospital, will be enrolled in our study.\n\nInclusion Criteria:\n\nAge 18 and above Witnessed cardiac arrest\n\nExclusion Criteria:\n\nTraumatic cardiac arrest Forensic cases Cardiac arrest secondary to ST-elevation myocardial infarction Patients in whom spontaneous circulation could not be achieved despite cardiopulmonary resuscitation lasting more than 20 minutes Patients with inaccessible past medical records or unknown medication history Patients without identification Unwitnessed cardiac arrest Pregnant patients\n\nPatients will be divided into two groups:\n\nThe first group will consist of 23 patients who used corticosteroid medications for any reason before experiencing cardiac arrest.\n\nThe second group will consist of 23 patients who did not use corticosteroid medications before cardiac arrest.\n\nFollowing successful cardiopulmonary resuscitation and restoration of spontaneous circulation, the following parameters will be recorded for both groups: need for vasopressor support, number of vasopressor agents used, maximum dose of vasopressor agent(s) required to maintain mean arterial pressure (MAP) \\>65 mmHg, duration of stay in intensive care unit/emergency department, mortality rate, length of hospital stay, patients' medical histories, age, and gender.\n\nThese parameters will be compared between the corticosteroid-using and non-using groups, and statistical analysis will be conducted to evaluate differences between the two groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients over the age of 18 with witnessed cardiac arrest', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 and above Witnessed cardiac arrest\n\nExclusion Criteria:\n\nTraumatic cardiac arrest Forensic cases Cardiac arrest secondary to ST-elevation myocardial infarction Patients in whom spontaneous circulation could not be achieved despite cardiopulmonary resuscitation lasting more than 20 minutes Patients with inaccessible past medical records or unknown medication history Patients without identification Unwitnessed cardiac arrest Pregnant patients'}, 'identificationModule': {'nctId': 'NCT06515327', 'briefTitle': 'Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients', 'orgStudyIdInfo': {'id': 'Corticosteroid Cardiac Arrest'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Steroid Group', 'description': 'Patients using corticosteroids for any reason before cardiac arrest'}, {'label': 'Non-Steroid Group', 'description': 'Patients not using corticosteroids and having cardiac arrest'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Ankara', 'state': 'Yenimahalle', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'gulsen akcay, ass. prof.', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'elif hamzacebioglu kayisoglu, specalist', 'role': 'CONTACT', 'email': 'turkuaz-61@windowslive.com', 'phone': '+905453300679'}, {'name': 'elif hamzacebioglu kayisoglu, specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'tayyar apa, resident', 'role': 'SUB_INVESTIGATOR'}, {'name': 'gulsen akcay, ass. prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'bedriye muge sonmez, ass.prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'murat özdemir, specialist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'gulsen akcay, ass. prof.', 'role': 'CONTACT', 'email': 'gulakcay@yahoo.com.tr', 'phone': '+905052874949'}, {'name': 'elif hamzacebioglu kayisoglu, specialist', 'role': 'CONTACT', 'email': 'turkuaz-61@windowslive.com', 'phone': '+905453300679'}], 'overallOfficials': [{'name': 'gulsen akcay, ass. prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ass. prof. of organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, {'name': 'Etimesgut Military Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}