Hypotension, Ischemia Reperfusion Injury
Conditions
Keywords
Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome
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.
Interventions
OTHERbolus purge
complete and uninterrupted purge
OTHERIntermittent purge
intermittent portal purge
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* living donor liver transplantation recipients
Exclusion criteria
* Non
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-reperfusion syndrome | 5 minutes after portal declamping | Reduced Mean arterial blood pressure to the predefined value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft ischemia reperfusion injury | one week post-operative | Pathological assessment of IR injury based on Suzuli score |
| Severity of post-reperfusion syndrome | 5 minutes after portal declamping | % decrease in Mean arterial blood pressure |
| One month patient mortality | one month post-operative | Mortality within one post-operative month |
Countries
Egypt
Contacts
Primary ContactAmr M Yassen, MD
Backup ContactAdel A Hassan, MD
Outcome results
None listed