Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-04-22 @ 11:57 AM
Study NCT ID:
NCT03097692
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019194', 'term': 'Ischemic Preconditioning'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intervention group well be pretreated with cardiac preconditioning'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-20', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-26', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of Neutrophil lymphocyte ratio', 'timeFrame': 'during first two postoperative days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac preconditioning', 'open heart surgery', 'createnine', 'inflammation'], 'conditions': ['Neutrophil Lymphocyte Ratio', 'Serum Createnine', 'Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation', 'detailedDescription': 'Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in 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* no active inflammatory process\n\nExclusion Criteria:Exclusion 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': 'NCT03097692', 'briefTitle': 'Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?', 'orgStudyIdInfo': {'id': 'IRB00009909'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ischemic preconditioing', 'description': '50 patients 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', 'interventionNames': ['Procedure: ischemic preconditioning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacologic preconditioing', 'description': 'by sevoflurane anesthesia', 'interventionNames': ['Drug: Pharmacologic preconditionig']}], 'interventions': [{'name': 'ischemic preconditioning', 'type': 'PROCEDURE', 'description': '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': ['Ischemic preconditioing']}, {'name': 'Pharmacologic preconditionig', 'type': 'DRUG', 'description': 'Pharmacologic preconditionig will be attained by sevoflurane anesthesia', 'armGroupLabels': ['Pharmacologic preconditioing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}