Ischemic Preconditioning of Liver in Cadaver Donors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00245830
First received: October 26, 2005
Last updated: January 16, 2015
Last verified: January 2015
  Purpose

The long-term goals of this proposal are to develop clinical protocols of donor preconditioning to improve liver graft function and ameliorate complications of poor graft function after liver transplantation. Achievement of these objectives would improve liver recipient outcomes, increase utilization of livers and alleviate the current critical shortage of livers for transplantation. More stringent liver donor selection intended to decrease the complications of poor graft function conflicts directly with efforts to maximize the use of donor livers. Ischemic preconditioning (IPC) of liver attenuates hepatic ischemia reperfusion injury (IRI) in animals. Preliminary data show hepatic IPC effectively decreases IRI following hepatic resection in humans.

The specific aims of this project are: AIM 1: To test the hypothesis that 10 minutes of hepatic ischemic preconditioning in deceased donors would improve liver graft function and decrease injury in the early post transplant period. AIM 2: To test the hypothesis that ischemic preconditioning of deceased donor livers would decrease systemic inflammatory response in liver recipients in the early post transplant period. AIM 3: To examine whether ischemic preconditioning of deceased donor livers decreases early post transplant pulmonary edema and acute rejection and shortens hospital stay.


Condition Intervention
Liver Cirrhosis
Liver Disease
Procedure: Ischemic Preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ischemic Preconditioning of Liver in Cadaver Donors

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Changes in INR/PT and serum AST, ALT and TB levels [ Time Frame: Values immediately post-transplantation and on days 1 - 3 and days 7, 14 and 30 post-transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma levels of cytokines [ Time Frame: Blood samples are collected at pre-incision of abdomen, cross-clamp of abdominal aorta; 3 hour postreprofusion and post-transplant day one in the recipient ] [ Designated as safety issue: No ]
  • Interstitial and alveolar edema in chest radiographs [ Time Frame: days 1 - 3 post transplant ] [ Designated as safety issue: No ]
  • Length of Hospital stay [ Time Frame: number of days from Liver transplant to hospital discharge on average 10 days ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2003
Study Completion Date: March 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Hepatic Ischemic Preconditioning
donor will act as a sham control.
Experimental: Hepatic Ischemic Preconditioning
blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.
Procedure: Ischemic Preconditioning
Experimental: Hepatic Ischemic Preconditioning blood flow to the liver will be cut off by hilar clamping for ten minutes followed by release of the clamp prior to removal of the liver from the donor.

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  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site.

Exclusion Criteria:

  1. Deceased donor livers allocated to recipients at centers other than the research site.
  2. Deceased donor livers allocated to recipients < 18 years of age at the research site.
  3. Non-heart beating donors
  4. Deceased liver and small intestine donors
  5. Live liver donors.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00245830

Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Baburao Koneru, M.D. UMDNJ-New Jersey Medical School
  More Information

Publications:
Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00245830     History of Changes
Other Study ID Numbers: 0120010348 
Study First Received: October 26, 2005
Last Updated: January 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Ischemia/reperfusion of the liver
Ischemic Preconditioning
Cadaver organ donor

Additional relevant MeSH terms:
Liver Diseases
Liver Cirrhosis
Cadaver
Digestive System Diseases
Death
Pathologic Processes

ClinicalTrials.gov processed this record on August 24, 2016