Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

Hypotension Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845154
• Other study ID #: LDLDPURGE
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2015
• Last updated: March 24, 2017
• Start date: October 2015
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: Mansoura University
• Contact: Amr M Yassen, MD
• Phone: +201001497044
• Email: amryassen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• living donor liver transplantation recipients

Exclusion Criteria:

• Non

Related Conditions & MeSH terms

• Hypotension
• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury

Intervention

Other:
• bolus purge
complete and uninterrupted purge
• Intermittent purge
intermittent portal purge

Locations

Country	Name	City	State
Egypt	Gastroenterology surgical center - Mansoura university	Mansoura	Dakahlia
Egypt	Liver transplantation program - Gastroenterology surgical center	Mansoura	Dakahlia
Egypt	Liver transplantation project - Gastroenterology surgical center - Mansoura university	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-reperfusion syndrome	Reduced Mean arterial blood pressure to the predefined value	5 minutes after portal declamping
Secondary	Graft ischemia reperfusion injury	Pathological assessment of IR injury based on Suzuli score	one week post-operative
Secondary	Severity of post-reperfusion syndrome	% decrease in Mean arterial blood pressure	5 minutes after portal declamping
Secondary	One month patient mortality	Mortality within one post-operative month	one month post-operative