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Ischemic Preconditioning of Liver in Cadaver Donors

This study has been completed.
Sponsor:
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00245830
First received: October 26, 2005
Last updated: April 27, 2007
Last verified: March 2007
History of Changes
  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 Phase
Liver Cirrhosis
Liver Transplantation
 Procedure: Ischemic Preconditioning
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • INR/PT and serum AST, ALT and TB levels

Secondary Outcome Measures:
  • Plasma levels of cytokines
  • Interstitial and alveolar edema in chest radiographs
  • Length of Hospital stay

Estimated Enrollment: 100
Study Start Date: October 2003
Study Completion Date: March 2007
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  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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
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 New Jersey
Investigators
Principal Investigator: Baburao Koneru, M.D. UMDNJ-New Jersey Medical School
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00245830     History of Changes
Other Study ID Numbers: 0120010348
Study First Received: October 26, 2005
Last Updated: April 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
Ischemia/reperfusion of the liver
Ischemic Preconditioning
Cadaver organ donor

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

ClinicalTrials.gov processed this record on May 22, 2013