Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

NCT ID: NCT02375269

Last Updated: 2015-03-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-03-31

Brief Summary

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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.

The purpose of this randomized controlled study is to investigate the influence and impact of RIPC on postoperative complications in patients undergoing visceral surgery

Detailed Description

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Conditions

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Postoperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

RIPC with a tourniquet

Intervention Type DEVICE

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RIPC with a tourniquet

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* \> 18 years
* Undergoing major visceral surgery

Exclusion Criteria

* \< 18 years
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Switzerland

Central Contacts

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Patryk Kambakamba, MD

Role: CONTACT

0442551111

Christian Oberkofler, MD

Role: CONTACT

0442551111

Facility Contacts

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Patryk Kambakamba, MD

Role: primary

044255111

Christian Oberkofler, MD

Role: backup

044255111

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.

Reference Type BACKGROUND
PMID: 24700614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23953384 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2014-0458

Identifier Type: -

Identifier Source: org_study_id

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