NCT04216407

Brief Summary

Ischemia-reperfusion (IR) injury during liver transplantation is one of the major causes of mortality and morbidity associated with transplantation. Remote organ ischemic preconditioning (RIPC) is one of the most investigated practices to reduce IR injury. In this study, for the first time in the clinic, the effect of RIPC will be evaluated via both systemic inflammation parameters and also parameters showing glycocalyx integrity, on living-donor liver recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

December 25, 2019

Last Update Submit

April 7, 2020

Conditions

Remote Organ Ischemic Preconditioning

Keywords

Remote organ ischemic preconditioningIschemia reperfusion injuryGlycocalyx integrity parametersSystemic inflammation parameters

Outcome Measures

Primary Outcomes (6)

  • Tumor necrosis factor-alpha (TNF-alpha)

    Evaluation of TNF-alpha level difference between groups

    Postoperative early period (6 hours after intensive care unite admission)

  • Intercellular adhesion molecule-1 (ICAM-1)

    Evaluation of (ICAM-1) level difference between group

    Postoperative early period (6 hours after intensive care unite admission)

  • Hypoxia-induced factor-1 (HIF-1)

    Evaluation of HIF-1 level difference between groups

    Postoperative early period (6 hours after intensive care unite admission)

  • Interleukin-8 (IL-8)

    Evaluation of IL-8 level difference between groups

    Postoperative early period (6 hours after intensive care unite admission)

  • Syndecan-1 (SDC-1)

    Evaluation of SDC-1 level difference between groups

    Postoperative early period (6 hours after intensive care unite admission)

  • soluble Vascular cell adhesion molecule-1 (sVCAM-1).

    Evaluation of sVCAM-1 level difference between groups

    Postoperative early period (6 hours after intensive care unite admission)

Secondary Outcomes (4)

  • Mortality

    7 days after surgery

  • Liver function tests

    7 days after surgery

  • Length of stay in hospital and intensive care unit

    7 days after surgery

  • Morbidity

    7 days after surgery

Study Arms (2)

Remote Ischemic Preconditioning

EXPERIMENTAL

Short-term tourniquet on to the lower extremity before surgery

Procedure: Remote ischemic preconditioning

Control

NO INTERVENTION

No intervention

Interventions

Remote ischemic preconditioningPROCEDURE

An orthopedic tourniquet was tied to the right lower extremities of the patients in RIPC arm, and tourniquet application was performed before the anhepatic phase in 3 periods of 3 minutes with an interval of 3 minutes.

Remote Ischemic Preconditioning

Eligibility Criteria

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

You may qualify if:

  • Patients followed up by Acıbadem Hospital Organ Transplantation Center
  • Patients accepted to participate in the study
  • Older than 18 years of age
  • ASA class III
  • MELD score \>12
  • Scheduled for elective liver transplantation surgery from a living donor

You may not qualify if:

  • Patients undergoing re-transplantation
  • Under the age of 18 years
  • Patients undergoing emergency surgery
  • Patients with hepatorenal or hepatopulmonary syndrome
  • Patients receiving mechanical ventilation support in the ICU
  • Patients refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Istanbul, Atakent, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 25, 2019

First Posted

January 2, 2020

Study Start

December 5, 2019

Primary Completion

January 17, 2020

Study Completion

March 20, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)