Clinical trial NCT02845154: Intermittent Portal and Graft Purge in Living Donor Liver Transplantation
Official title: Intermittent Anti-grade Portal and Graft Purge Ameliorates Post-reperfusion Syndrome in Living Donor Liver Transplantation Recipients. A Prospective, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Ischemia Reperfusion Injury
Keywords: Ischemia reperfusion
post-reperfusion syndrome
living donor liver transplantation
patient outcome
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* living donor liver transplantation recipients

Exclusion Criteria:

* Non

Primary outcomes:
measure: Post-reperfusion syndrome
timeFrame: 5 minutes after portal declamping
Secondary outcomes:
measure: Graft ischemia reperfusion injury
timeFrame: one week post-operative
measure: Severity of post-reperfusion syndrome
timeFrame: 5 minutes after portal declamping
measure: One month patient mortality
timeFrame: one month post-operative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Liver transplantation program - Gastroenterology surgical center
state: Dakahlia
city: Mansoura
country: Egypt
facility: Liver transplantation project - Gastroenterology surgical center - Mansoura university
state: Dakahlia
city: Mansoura
country: Egypt
facility: Gastroenterology surgical center - Mansoura university
state: Dakahlia
Study officials:
affiliation: Mansoura Faculty of Medicine
name: Amr M Yassen, MD
role: STUDY_DIRECTOR
References: