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Intermittent Portal and Graft Purge in Living Donor Liver Transplantation (IPLDLT)

Primary Purpose

Hypotension, Ischemia Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bolus purge
Intermittent purge
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension focused on measuring Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • living donor liver transplantation recipients

Exclusion Criteria:

  • Non

Sites / Locations

  • Liver transplantation program - Gastroenterology surgical centerRecruiting
  • Liver transplantation project - Gastroenterology surgical center - Mansoura universityRecruiting
  • Gastroenterology surgical center - Mansoura universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control (bolus purge)

Intermittent Purge

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Post-reperfusion syndrome
Reduced Mean arterial blood pressure to the predefined value

Secondary Outcome Measures

Graft ischemia reperfusion injury
Pathological assessment of IR injury based on Suzuli score
Severity of post-reperfusion syndrome
% decrease in Mean arterial blood pressure
One month patient mortality
Mortality within one post-operative month

Full Information

First Posted
October 16, 2015
Last Updated
March 24, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT02845154
Brief Title
Intermittent Portal and Graft Purge in Living Donor Liver Transplantation
Acronym
IPLDLT
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Ischemia Reperfusion Injury
Keywords
Ischemia reperfusion, post-reperfusion syndrome, living donor liver transplantation, patient outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control (bolus purge)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intermittent Purge
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
bolus purge
Intervention Description
complete and uninterrupted purge
Intervention Type
Other
Intervention Name(s)
Intermittent purge
Intervention Description
intermittent portal purge
Primary Outcome Measure Information:
Title
Post-reperfusion syndrome
Description
Reduced Mean arterial blood pressure to the predefined value
Time Frame
5 minutes after portal declamping
Secondary Outcome Measure Information:
Title
Graft ischemia reperfusion injury
Description
Pathological assessment of IR injury based on Suzuli score
Time Frame
one week post-operative
Title
Severity of post-reperfusion syndrome
Description
% decrease in Mean arterial blood pressure
Time Frame
5 minutes after portal declamping
Title
One month patient mortality
Description
Mortality within one post-operative month
Time Frame
one month post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: living donor liver transplantation recipients Exclusion Criteria: Non
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr M Yassen, MD
Phone
+201001497044
Email
amryassen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adel A Hassan, MD
Phone
+201007921234
Email
apoadel2004@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Liver transplantation program - Gastroenterology surgical center
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Phone
+201001497044
Email
amryassen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Waleed R alsarraf, MD
Phone
+201222322727
Email
welsarraf@yahoo.com
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Facility Name
Liver transplantation project - Gastroenterology surgical center - Mansoura university
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Phone
+201001497044
Email
amryassen@hotmail.com
First Name & Middle Initial & Last Name & Degree
Waleed R Elsarraf, MD
Phone
+201222322727
Email
welsarraf@gmail.com
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Elmorshidy, MD
First Name & Middle Initial & Last Name & Degree
Elrefaiee Kandil, MD
First Name & Middle Initial & Last Name & Degree
Usama Elsaied, MD
First Name & Middle Initial & Last Name & Degree
Waleed R Elsarraf, MD
First Name & Middle Initial & Last Name & Degree
Adel Hassan, MD
Facility Name
Gastroenterology surgical center - Mansoura university
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr M Yassen, MD
Phone
+201001497044
Email
amryassen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

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