NCT02375269

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 2, 2015

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

February 24, 2015

Last Update Submit

February 27, 2015

Conditions

Postoperative Complication

Keywords

Visceral SurgeryComprehensive Complication IndexPatient undergoing abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Complications

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

    30 days

Secondary Outcomes (3)

  • Hospital stay

    30 days

  • ICU stay

    30 days

  • Infection composite parameters

    30 days

Study Arms (2)

RIPC (Remote Ischemic Preconditioning)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

RIPC with a tourniquetDEVICE
RIPC (Remote Ischemic Preconditioning)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years
  • Undergoing major visceral surgery

You may not qualify if:

  • \< 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Zurich, Canton of Zurich, 8006, Switzerland

Location

Related 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.

    PMID: 24700614BACKGROUND

  • 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.

    PMID: 23953384BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre- Alain Clavien, MD, Phd

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patryk Kambakamba, MD

CONTACT

0442551111patryk.kambakamba@usz.ch

Christian Oberkofler, MD

CONTACT

0442551111christian.oberkofler@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2015

First Posted

March 2, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 2, 2015

Record last verified: 2015-01

Locations

CH(1)