Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

NCT02845154 | Unknown

• 1 other identifier: LDLDPURGE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypotension; Ischemia Reperfusion Injury

Keywords

Ischemia reperfusion; post-reperfusion syndrome; living donor liver transplantation; patient outcome

Outcome Measures

Primary Outcomes (1)

• Post-reperfusion syndrome

  Reduced Mean arterial blood pressure to the predefined value

  5 minutes after portal declamping

Secondary Outcomes (3)

• Graft ischemia reperfusion injury

  one week post-operative

• Severity of post-reperfusion syndrome

  5 minutes after portal declamping

• One month patient mortality

  one month post-operative

Study Arms (2)

Control (bolus purge)

ACTIVE COMPARATOR

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

Intermittent Purge

EXPERIMENTAL

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

Interventions

bolus purge OTHER

complete and uninterrupted purge

Control (bolus purge)

Intermittent purge OTHER

intermittent portal purge

Intermittent Purge

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• living donor liver transplantation recipients

You may not qualify if:

• Non

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (3)

Liver transplantation program - Gastroenterology surgical center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Hypotension; Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amr M Yassen, MD

  Mansoura Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Amr M Yassen, MD

CONTACT

+201001497044; amryassen@hotmail.com

Adel A Hassan, MD

CONTACT

+201007921234; apoadel2004@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: July 27, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 27, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)