Purge Vs no Purge in Living Donor Liver Transplantation Recipients

Ischemia Reperfusion Injury Clinical Trial

— PNP  

Official title:

Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540447
• Other study ID #: Purge_LTX
• Status: Completed
• Phase: N/A
• First received: August 30, 2015
• Last updated: September 21, 2015
• Start date: January 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.

Description:

All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

Exclusion Criteria:

• re-transplantation

• Previous upper abdominal operation

• Budd Chiari syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia Reperfusion Injury
• Reperfusion Injury

Intervention

Other:
• Purge of graft contents out of the circulation
In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping

Locations

Country	Name	City	State
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	Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure	The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping	5 minutes post-reperfusion	No
Secondary	Physiological Parameters	Arterial blood pressure, pulmonary catheter derived parameters	12 hours	No
Secondary	Ischemia Reperfusion Injury	incidence of ischemia reperfusion injury in the transplanted graft	7 days	No
Secondary	Post-operative Complications	pulmonary complications, graft dysfunction	7 days	No
Secondary	Patient Survival	mortality at 30 days	30 days	No