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

Not Applicable

Completed

• Conditions: Remote Organ Ischemic Preconditioning
• Interventions: Procedure: Remote ischemic preconditioning

• Registration Number: NCT04216407
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Primary Completion: 2020-01-17
• Study Completion: 2020-03-20
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning	Remote ischemic preconditioning	Short-term tourniquet on to the lower extremity before surgery

Primary Outcome Measures

Name	Time	Method
Intercellular adhesion molecule-1 (ICAM-1)	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of (ICAM-1) level difference between group
Syndecan-1 (SDC-1)	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of SDC-1 level difference between groups
Tumor necrosis factor-alpha (TNF-alpha)	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of TNF-alpha level difference between groups
Hypoxia-induced factor-1 (HIF-1)	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of HIF-1 level difference between groups
Interleukin-8 (IL-8)	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of IL-8 level difference between groups
soluble Vascular cell adhesion molecule-1 (sVCAM-1).	Postoperative early period (6 hours after intensive care unite admission)	Evaluation of sVCAM-1 level difference between groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Acıbadem Mehmet Ali Aydinlar University Atakent Hospital; 🇹🇷 Istanbul, Atakent, Turkey