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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216407
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Acibadem University

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.

Condition or disease Intervention/treatment Phase
Remote Organ Ischemic Preconditioning Procedure: Remote ischemic preconditioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects Of Remote Organ Ischemic Preconditioning On Systemic Inflammatory And Glycocalyx Integrity Parameters In Living-Donor Liver Transplantation Patients
Actual Study Start Date : December 5, 2019
Actual Primary Completion Date : January 17, 2020
Actual Study Completion Date : March 20, 2020

Arm Intervention/treatment
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.

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. Tumor necrosis factor-alpha (TNF-alpha) [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of TNF-alpha level difference between groups

  2. Intercellular adhesion molecule-1 (ICAM-1) [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of (ICAM-1) level difference between group

  3. Hypoxia-induced factor-1 (HIF-1) [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of HIF-1 level difference between groups

  4. Interleukin-8 (IL-8) [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of IL-8 level difference between groups

  5. Syndecan-1 (SDC-1) [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of SDC-1 level difference between groups

  6. soluble Vascular cell adhesion molecule-1 (sVCAM-1). [ Time Frame: Postoperative early period (6 hours after intensive care unite admission) ]
    Evaluation of sVCAM-1 level difference between groups


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 7 days after surgery ]
    Early postoperative mortality

  2. Liver function tests [ Time Frame: 7 days after surgery ]
    Evaluation of early postoperative liver function tests; AST and ALT

  3. Length of stay in hospital and intensive care unit [ Time Frame: 7 days after surgery ]
    Evaluation of the length of stay in hospital and intensive care unit

  4. Morbidity [ Time Frame: 7 days after surgery ]
    Early postoperative complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216407


Locations
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Turkey
Acıbadem Mehmet Ali Aydinlar University Atakent Hospital
Istanbul, Atakent, Turkey, 34303
Sponsors and Collaborators
Acibadem University
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Responsible Party: Acibadem University
ClinicalTrials.gov Identifier: NCT04216407    
Other Study ID Numbers: 2019-01/02
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acibadem University:
Remote organ ischemic preconditioning
Ischemia reperfusion injury
Glycocalyx integrity parameters
Systemic inflammation parameters
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes