Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.

Detailed Description
-----------------
Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.

Official Title
-----------------
Intermittent Anti-grade Portal and Graft Purge Ameliorates Post-reperfusion Syndrome in Living Donor Liver Transplantation Recipients. A Prospective, Randomised Controlled Trial

Conditions
-----------------
Hypotension, Ischemia Reperfusion Injury

Intervention / Treatment
-----------------
* Other: bolus purge
* Other: Intermittent purge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living donor liver transplantation recipients Exclusion Criteria: Non

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (bolus purge)<br>The portal vein clamp will be totally released after end of portal vein anastomosis and all graft and portal blood contents are allowed free and complete access to the systemic circulation via the inferior vena cave | Other: bolus purge<br>* complete and uninterrupted purge<br>|
| Experimental: Intermittent Purge<br>The portal clamp will be released in situ for 5 seconds to allow purge of the graft and portal contents into the systemic circulation, followed by 30 seconds of portal clamping again. This will be followed by another two cycles of 5 seconds declamping and 30 seconds clamping , then, the portal clamp will be completely released. | Other: Intermittent purge<br>* intermittent portal purge<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-reperfusion syndrome | Reduced Mean arterial blood pressure to the predefined value | 5 minutes after portal declamping | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft ischemia reperfusion injury | Pathological assessment of IR injury based on Suzuli score | one week post-operative | 
| Severity of post-reperfusion syndrome | % decrease in Mean arterial blood pressure | 5 minutes after portal declamping | 
| One month patient mortality | Mortality within one post-operative month | one month post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome