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

Remote Organ Ischemic Preconditioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216407
• Other study ID #: 2019-01/02
• Status: Completed
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: April 2020
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 20, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients followed up by Acibadem 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

Related Conditions & MeSH terms

• Ischemia
• Remote Organ Ischemic Preconditioning

Intervention

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.

Locations

Country	Name	City	State
Turkey	Acibadem Mehmet Ali Aydinlar University Atakent Hospital	Istanbul	Atakent

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor necrosis factor-alpha (TNF-alpha)	Evaluation of TNF-alpha level difference between groups	Postoperative early period (6 hours after intensive care unite admission)
Primary	Intercellular adhesion molecule-1 (ICAM-1)	Evaluation of (ICAM-1) level difference between group	Postoperative early period (6 hours after intensive care unite admission)
Primary	Hypoxia-induced factor-1 (HIF-1)	Evaluation of HIF-1 level difference between groups	Postoperative early period (6 hours after intensive care unite admission)
Primary	Interleukin-8 (IL-8)	Evaluation of IL-8 level difference between groups	Postoperative early period (6 hours after intensive care unite admission)
Primary	Syndecan-1 (SDC-1)	Evaluation of SDC-1 level difference between groups	Postoperative early period (6 hours after intensive care unite admission)
Primary	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	Mortality	Early postoperative mortality	7 days after surgery
Secondary	Liver function tests	Evaluation of early postoperative liver function tests; AST and ALT	7 days after surgery
Secondary	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
Secondary	Morbidity	Early postoperative complications	7 days after surgery