Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery (RIPC)

University of Zurich (UZH)

Status: Unknown

Conditions: Postoperative Complication

Treatments: Device: RIPC with a tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT02375269

KEK-ZH-Nr. 2014-0458

Details and patient eligibility

About

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

Enrollment: 526 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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526 participants in 2 patient groups

RIPC (Remote Ischemic Preconditioning)

Experimental group

Description:

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.

Treatment:

Device: RIPC with a tourniquet

Control

No Intervention group

Description:

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.