search
Back to results

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

Primary Purpose

Postoperative Complication

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
RIPC with a tourniquet
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complication focused on measuring Visceral Surgery, Comprehensive Complication Index, Patient undergoing abdominal surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RIPC (Remote Ischemic Preconditioning)

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

Postoperative Complications
Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score

Secondary Outcome Measures

Hospital stay
ICU stay
Infection composite parameters
CRP, Procalcitonin, Leucocytes

Full Information

First Posted
February 24, 2015
Last Updated
February 27, 2015
Sponsor
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT02375269
Brief Title
Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complication
Keywords
Visceral Surgery, Comprehensive Complication Index, Patient undergoing abdominal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
526 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC (Remote Ischemic Preconditioning)
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
RIPC with a tourniquet
Primary Outcome Measure Information:
Title
Postoperative Complications
Description
Complications will be assessed by Comprehensive Complication Index and Dindo Clavien Score
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital stay
Time Frame
30 days
Title
ICU stay
Time Frame
30 days
Title
Infection composite parameters
Description
CRP, Procalcitonin, Leucocytes
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patryk Kambakamba, MD
Phone
0442551111
Email
patryk.kambakamba@usz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Oberkofler, MD
Phone
0442551111
Email
christian.oberkofler@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre- Alain Clavien, MD, Phd
Organizational Affiliation
Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Swiss HPB and Transplant Surgery, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8006
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patryk Kambakamba, MD
Phone
044255111
Email
patryk.kambakamba@usz.ch
First Name & Middle Initial & Last Name & Degree
Christian Oberkofler, MD
Phone
044255111
Email
christian.oberkofler@usz.ch

12. IPD Sharing Statement

Citations:
PubMed Identifier
24700614
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.
Results Reference
background
PubMed Identifier
23953384
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. Erratum In: Lancet. 2013 Sep 14;382(9896):940.
Results Reference
background

Learn more about this trial

Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery

We'll reach out to this number within 24 hrs