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The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters

Primary Purpose

Remote Organ Ischemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Remote Organ Ischemic Preconditioning focused on measuring Remote organ ischemic preconditioning, Ischemia reperfusion injury, Glycocalyx integrity parameters, Systemic inflammation parameters

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remote Ischemic Preconditioning

Control

Arm Description

Short-term tourniquet on to the lower extremity before surgery

No intervention

Outcomes

Primary Outcome Measures

Tumor necrosis factor-alpha (TNF-alpha)
Evaluation of TNF-alpha level difference between groups
Intercellular adhesion molecule-1 (ICAM-1)
Evaluation of (ICAM-1) level difference between group
Hypoxia-induced factor-1 (HIF-1)
Evaluation of HIF-1 level difference between groups
Interleukin-8 (IL-8)
Evaluation of IL-8 level difference between groups
Syndecan-1 (SDC-1)
Evaluation of SDC-1 level difference between groups
soluble Vascular cell adhesion molecule-1 (sVCAM-1).
Evaluation of sVCAM-1 level difference between groups

Secondary Outcome Measures

Mortality
Early postoperative mortality
Liver function tests
Evaluation of early postoperative liver function tests; AST and ALT
Length of stay in hospital and intensive care unit
Evaluation of the length of stay in hospital and intensive care unit
Morbidity
Early postoperative complications

Full Information

First Posted
December 25, 2019
Last Updated
April 7, 2020
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT04216407
Brief Title
The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters
Official Title
The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Remote Organ Ischemic Preconditioning
Keywords
Remote organ ischemic preconditioning, Ischemia reperfusion injury, Glycocalyx integrity parameters, Systemic inflammation parameters

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischemic Preconditioning
Arm Type
Experimental
Arm Description
Short-term tourniquet on to the lower extremity before surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor necrosis factor-alpha (TNF-alpha)
Description
Evaluation of TNF-alpha level difference between groups
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Title
Intercellular adhesion molecule-1 (ICAM-1)
Description
Evaluation of (ICAM-1) level difference between group
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Title
Hypoxia-induced factor-1 (HIF-1)
Description
Evaluation of HIF-1 level difference between groups
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Title
Interleukin-8 (IL-8)
Description
Evaluation of IL-8 level difference between groups
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Title
Syndecan-1 (SDC-1)
Description
Evaluation of SDC-1 level difference between groups
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Title
soluble Vascular cell adhesion molecule-1 (sVCAM-1).
Description
Evaluation of sVCAM-1 level difference between groups
Time Frame
Postoperative early period (6 hours after intensive care unite admission)
Secondary Outcome Measure Information:
Title
Mortality
Description
Early postoperative mortality
Time Frame
7 days after surgery
Title
Liver function tests
Description
Evaluation of early postoperative liver function tests; AST and ALT
Time Frame
7 days after surgery
Title
Length of stay in hospital and intensive care unit
Description
Evaluation of the length of stay in hospital and intensive care unit
Time Frame
7 days after surgery
Title
Morbidity
Description
Early postoperative complications
Time Frame
7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
City
Istanbul
State/Province
Atakent
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters

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