Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT02715869
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-09', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-21', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highest inotropic score', 'timeFrame': 'first 24 hour'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Preconditioning, inotropic score'], 'conditions': ['Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be (ischemic ; pharmacologic or Physical).', 'detailedDescription': 'Preconditioning (PC) of the heart occurs when brief exposure to a stimulus protects the heart from subsequent ischemia. PC stimulus may be ( ischemic ; pharmacologic or Physical)\n\nPharmacological PC may be induced by variable agents e.g. (Sevoflurane ;isoflorane, opioids etc)\n\nIschemic PC includes local; remote and the idea is temporary interruption of blood supply to the organ so that liberation of protective mediators occurs. The liberated mediators have favorable effects not only upon the myocardium, but it extend to protect other organs against inflammatory activation; ischemia reperfusion injury\n\nInotropic score (IS) is already an evident predictor of postoperative cardiac morbidity and mortality\n\nAim of the work:\n\nIs to validate the impact of Sevoflurane versus ischemic \\& Sevoflurane PC upon postoperative inotropic score in adult patient undergoing open heart surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years old\n* American Society of Anesthesiologists physical status II and III\n* Patients scheduled for open heart surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Clinically significant kidney or liver disease\n* Patients allergic to local anesthetic\n* Patients with prolonged cardiopulmonary bypass time (\\>120 min)\n* Patients required intra-aortic balloon pump\n* Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration'}, 'identificationModule': {'nctId': 'NCT02715869', 'briefTitle': 'Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Variable Types of Preconditioning Upon the Inotrope Score in Adult Patients, Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': 'IRB00009901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A pharmacologic cardiac preconditioning', 'description': 'Sevoflurane as a pharmacologic preconditioner for the heart', 'interventionNames': ['Drug: A pharmacologic cardiac preconditioning (Sevoflurane)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B ischeamic preconditioning', 'description': 'ischemic preconditioning by inflation the cuff of blood pressure', 'interventionNames': ['Procedure: B ischeamic preconditioning']}], 'interventions': [{'name': 'A pharmacologic cardiac preconditioning (Sevoflurane)', 'type': 'DRUG', 'description': 'A Patients are anaesthetized by Sevoflurane more than 1 mac.', 'armGroupLabels': ['A pharmacologic cardiac preconditioning']}, {'name': 'B ischeamic preconditioning', 'type': 'PROCEDURE', 'description': 'B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles', 'armGroupLabels': ['B ischeamic preconditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Emad Zarief Kamel Said, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesia, faculty of Medicine, Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and critical care Medicine', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}