Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

Postoperative Complication Clinical Trial

— RIPC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02375269
• Other study ID #: KEK-ZH-Nr. 2014-0458
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2015
• Last updated: February 27, 2015
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2015
• Source: University of Zurich
• Contact: Patryk Kambakamba, MD
• Phone: 0442551111
• Email: patryk.kambakamba[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 526
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postoperative Complication
• Postoperative Complications

Intervention

Device:
• RIPC with a tourniquet

Locations

Country	Name	City	State
Switzerland	Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhäuser 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. Erratum in: Lancet. 2013 Sep 14;382(9896):940. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Complications	Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score	30 days	No
Secondary	Hospital stay		30 days	No
Secondary	ICU stay		30 days	No
Secondary	Infection composite parameters	CRP, Procalcitonin, Leucocytes	30 days	No