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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypotension; Ischemia Reperfusion Injury
• Intervention / Treatment: Other: bolus purge; Other: Intermittent purge

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adel A Hassan, MD; Phone Number: +201007921234; Email: apoadel2004@yahoo.com

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Recruiting
      • Liver transplantation project - Gastroenterology surgical center - Mansoura university
      • Principal Investigator: Amr M Yassen, MD
      • Sub-Investigator: Mohamed Elmorshidy, MD
      • Sub-Investigator: Elrefaiee Kandil, MD
      • Sub-Investigator: Usama Elsaied, MD
      • Sub-Investigator: Waleed R Elsarraf, MD
      • Sub-Investigator: Adel Hassan, MD
    • Mansoura, Dakahlia, Egypt, 35511
      • Recruiting
      • Liver transplantation program - Gastroenterology surgical center
      • Principal Investigator: Amr M Yassen, MD
      • Contact: Waleed R alsarraf, MD; Phone Number: +201222322727; Email: welsarraf@yahoo.com
    • Mansoura, Dakahlia, Egypt, 35516
      • Recruiting
      • Gastroenterology surgical center - Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• living donor liver transplantation recipients

Exclusion Criteria:

• Non

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (bolus purge); 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; complete and uninterrupted purge
Experimental: Intermittent Purge; 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; intermittent portal purge

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Amr M Yassen, MD, Mansoura faculty of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: living donor liver transplantation; patient outcome; Ischemia reperfusion; post-reperfusion syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury; Hypotension
• Other Study ID Numbers: LDLDPURGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No