Skip to main content
OpenTrials
Completed

NCT Number: NCT04216407

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Remote Organ Ischemic Preconditioning Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acıbadem Mehmet Ali Aydinlar University Atakent Hospital

Istanbul, Atakent, 34303, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 2, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.