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

February 27, 2015 updated by: University of Zurich

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

526

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: RIPC with a tourniquet
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications
Time Frame: 30 days
Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 30 days
30 days
ICU stay
Time Frame: 30 days
30 days
Infection composite parameters
Time Frame: 30 days
CRP, Procalcitonin, Leucocytes
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Pierre- Alain Clavien, MD, Phd, Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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