Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-20 @ 8:25 PM
Study NCT ID:
NCT02375269
Status:
UNKNOWN
Last Update Posted:
2015-03-02
First Post:
2015-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 526}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-27', 'studyFirstSubmitDate': '2015-02-24', 'studyFirstSubmitQcDate': '2015-02-27', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Complications', 'timeFrame': '30 days', 'description': 'Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score'}], 'secondaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': '30 days'}, {'measure': 'ICU stay', 'timeFrame': '30 days'}, {'measure': 'Infection composite parameters', 'timeFrame': '30 days', 'description': 'CRP, Procalcitonin, Leucocytes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Visceral Surgery', 'Comprehensive Complication Index', 'Patient undergoing abdominal surgery'], 'conditions': ['Postoperative Complication']}, 'referencesModule': {'references': [{'pmid': '24700614', 'type': 'BACKGROUND', 'citation': 'Oberkofler CE, Limani P, Jang JH, Rickenbacher A, Lehmann K, Raptis DA, Ungethuem U, Tian Y, Grabliauskaite K, Humar R, Graf R, Humar B, Clavien PA. Systemic protection through remote ischemic preconditioning is spread by platelet-dependent signaling in mice. Hepatology. 2014 Oct;60(4):1409-17. doi: 10.1002/hep.27089. Epub 2014 Aug 13.'}, {'pmid': '23953384', 'type': 'BACKGROUND', 'citation': 'Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6.'}]}, 'descriptionModule': {'briefSummary': 'Remote Ischemic Preconditioning (RIPC) is mediated by intermittent brief episodes (5-10 minutes) of short ischemia in a limb (i.e. arm), followed by reperfusion. For this purpose in 3-4 cycles, a tourniquet is insufflated to suprasystolic pressure levels for 5 minutes and deflated for 5 minutes afterwards. The ischemic episodes are known to stimulate platelets and factors platelet dependent factors such as Serotonin and VEGF. These humoral factors have a systemic effect and have the potential to protect target organs (i.e. heart, kidney, liver) remote to the ischemic limb.\n\nThe purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* Undergoing major visceral surgery\n\nExclusion Criteria:\n\n* \\< 18 years\n* Pregnancy\n* Signs of Infection/Inflammation on upper limb\n* Shunt\n* Medical history of axillary lymph node dissection\n* Signs of malperfusion of upper limb (i.e. Allen Test)\n* Missing informed consent'}, 'identificationModule': {'nctId': 'NCT02375269', 'acronym': 'RIPC', 'briefTitle': 'Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Randomized, Double- Blind Multicentric Study of the Effect of Remote Ischemic Preconditioning on Postoperative Complications in Patients Undergoing Major Minimal and Open Visceral Surgery', 'orgStudyIdInfo': {'id': 'KEK-ZH-Nr. 2014-0458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC (Remote Ischemic Preconditioning)', 'description': 'Preoperatively in the operation theater a tourniquet will be applied to the left arm and RIPC will performed. Therefore the tourniquet will be insufflated to suprasystolic pressure levels for 5 minutes, followed by 5 minutes reperfusion (deflated). Three cycles are planned. Duration of the procedure is 30 minutes.', 'interventionNames': ['Device: RIPC with a tourniquet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Preoperatively in the operation theater a tourniquet will be applied to the left arm. The tourniquet will not be insufflated. The tourniquet will be removed after 30 minutes.'}], 'interventions': [{'name': 'RIPC with a tourniquet', 'type': 'DEVICE', 'armGroupLabels': ['RIPC (Remote Ischemic Preconditioning)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8006', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Patryk Kambakamba, MD', 'role': 'CONTACT', 'email': 'patryk.kambakamba@usz.ch', 'phone': '044255111'}, {'name': 'Christian Oberkofler, MD', 'role': 'CONTACT', 'email': 'christian.oberkofler@usz.ch', 'phone': '044255111'}], 'facility': 'Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Patryk Kambakamba, MD', 'role': 'CONTACT', 'email': 'patryk.kambakamba@usz.ch', 'phone': '0442551111'}, {'name': 'Christian Oberkofler, MD', 'role': 'CONTACT', 'email': 'christian.oberkofler@usz.ch', 'phone': '0442551111'}], 'overallOfficials': [{'name': 'Pierre- Alain Clavien, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}