Clinical trial NCT02375269: Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complication
Keywords: Visceral Surgery
Comprehensive Complication Index
Patient undergoing abdominal surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Complications
timeFrame: 30 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 30 days
measure: ICU stay
timeFrame: 30 days
measure: Infection composite parameters
timeFrame: 30 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich
Study officials:
affiliation: Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich, Switzerland
name: Pierre- Alain Clavien, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.