Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery
NCT ID: NCT02375269
Last Updated: 2015-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
526 participants
INTERVENTIONAL
2015-03-31
2018-03-31
Brief Summary
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The purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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RIPC (Remote Ischemic Preconditioning)
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.
RIPC with a tourniquet
Control
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.
No interventions assigned to this group
Interventions
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RIPC with a tourniquet
Eligibility Criteria
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Inclusion Criteria
* Undergoing major visceral surgery
Exclusion Criteria
* Pregnancy
* Signs of Infection/Inflammation on upper limb
* Shunt
* Medical history of axillary lymph node dissection
* Signs of malperfusion of upper limb (i.e. Allen Test)
* Missing informed consent
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Pierre- Alain Clavien, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich, Switzerland
Locations
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Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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KEK-ZH-Nr. 2014-0458
Identifier Type: -
Identifier Source: org_study_id
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