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Clinical Trials/NCT02845154
NCT02845154
Unknown
Not Applicable

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

Mansoura University3 sites in 1 country80 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Mansoura University
Enrollment
80
Locations
3
Primary Endpoint
Post-reperfusion syndrome
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
November 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Mohamed Yassen

Professor of Anesthesia and Intensive Care

Mansoura University

Eligibility Criteria

Inclusion Criteria

  • living donor liver transplantation recipients

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Post-reperfusion syndrome

Time Frame: 5 minutes after portal declamping

Reduced Mean arterial blood pressure to the predefined value

Secondary Outcomes

  • Severity of post-reperfusion syndrome(5 minutes after portal declamping)
  • One month patient mortality(one month post-operative)
  • Graft ischemia reperfusion injury(one week post-operative)

Study Sites (3)

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