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

The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients

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.

Study Overview

• Status: Completed
• Conditions: Remote Organ Ischemic Preconditioning
• Intervention / Treatment: Procedure: Remote ischemic preconditioning

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atakent
    • Istanbul, Atakent, Turkey, 34303
      • Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention
Experimental: Remote Ischemic Preconditioning; Short-term tourniquet on to the lower extremity before surgery	Procedure: Remote ischemic preconditioning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Early postoperative mortality	7 days after surgery
Liver function tests	Evaluation of early postoperative liver function tests; AST and ALT	7 days after surgery
Length of stay in hospital and intensive care unit	Evaluation of the length of stay in hospital and intensive care unit	7 days after surgery
Morbidity	Early postoperative complications	7 days after surgery

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 30, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Ischemia reperfusion injury; Remote organ ischemic preconditioning; Glycocalyx integrity parameters; Systemic inflammation parameters
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: 2019-01/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No