Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-28 @ 10:48 AM
Study NCT ID:
NCT01910961
Status:
UNKNOWN
Last Update Posted:
2013-07-30
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-26', 'studyFirstSubmitDate': '2013-06-27', 'studyFirstSubmitQcDate': '2013-07-26', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'hospitalization costs', 'timeFrame': '30 days after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '36645250', 'type': 'DERIVED', 'citation': 'Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality, hospitalization costs and quality of life in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.', 'detailedDescription': 'Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators have revealed that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.Few groups have investigated the long term influence of limb remote ischemic preconditioning.Therefore, the investigators evaluated the impact of limb remote ischemic preconditioning on mortality, hospitalization costs and quality of life during elective abdominal aortic aneurysm repair in a prospective, randomized, controlled, single blind setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of abdominal aortic aneurysm\n* Must be received open abdominal aortic aneurysm repair\n\nExclusion Criteria:\n\n* age \\>80 years old\n* Acute coronary syndrome or myocardial infraction within 3 months\n* Chronic obstructive pulmonary emphysema\n* angina pain within 48 hours of repair procedure\n* ejection fraction less than 40%\n* poor pulmonary function (PaO2 \\<60mmHg)'}, 'identificationModule': {'nctId': 'NCT01910961', 'briefTitle': 'Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LRIP'}, 'secondaryIdInfos': [{'id': 'Liu Kexuan', 'type': 'OTHER_GRANT', 'domain': 'from National Natural Science Foundation, Beijing, China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'limb RIPC', 'description': 'limb RIPC protocol was applied after anesthetic induction and before the start of surgery. The limb RIPC was induced by placing a blood pressure cuff on the left upper arm of patient for three inflating-deflating cycles: 5 min inflating to 200 mmHg followed by a 5 min reperfusion with deflating the cuff.', 'interventionNames': ['Procedure: limb RIPC']}, {'type': 'NO_INTERVENTION', 'label': 'convention', 'description': 'Adult patients undergoing elective open abdominal aortic aneurysm repair received no treatment after induction of anaesthesia.The control group had an uninflated cuff placed on the left upper arm for 30 min.'}], 'interventions': [{'name': 'limb RIPC', 'type': 'PROCEDURE', 'otherNames': ['limb remote ischemic preconditioning'], 'description': 'LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated', 'armGroupLabels': ['limb RIPC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cai Li, MD', 'role': 'CONTACT', 'email': 'licaigz@yahoo.com.cn', 'phone': '+86-18602017796'}], 'overallOfficials': [{'name': 'Kexuan Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cai Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Cai Li', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}