Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

Not Applicable

• Conditions: Postoperative Complication
• Interventions: Device: RIPC with a tourniquet

• Registration Number: NCT02375269
• Lead Sponsor: University of Zurich

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study Start: 2015-03
• Study First Posted: 2015-03-02
• Last Update Posted: 2015-03-02
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 526

Inclusion Criteria

• > 18 years
• Undergoing major visceral surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC (Remote Ischemic Preconditioning)	RIPC with a tourniquet	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	30 days	Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score

Secondary Outcome Measures

Name	Time	Method
ICU stay	30 days
Infection composite parameters	30 days	CRP, Procalcitonin, Leucocytes
Hospital stay	30 days

Trial Locations

Locations (1)

Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich; 🇨🇭 Zurich, Switzerland