Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability
1 other identifier
observational
17
1 country
1
Brief Summary
The primary goal of this project is to identify the source of cytokines that are released into circulation during graft reperfusion. Seventeen patients scheduled to have adult cadaveric liver transplantation at the Milton S. Hershey Medical Center were contacted as prospective participants. Blood samples were obtained from the radial artery, the portal vein, and from the graft irrigation. The level of pro-inflammatory cytokines was verified and compared with the amount of catecholamines used to maintain hemodynamic stability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 11, 2010
CompletedNovember 24, 2017
November 1, 2017
1.7 years
May 3, 2010
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of cytokine levels (TNF-alpha, IL-1, Il-2, IL-6, IL-8) in the portal vein, radial artery and "flush" (from irrigation of the liver used to remove preservation solution from the liver graft) blood.
Cytokines released from the liver graft could be a cause for negative inotropy and systemic vasodilatation.
A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion.
Secondary Outcomes (1)
Correlation between the level of cytokines and hemodynamic stability during reperfusion.
A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion.
Eligibility Criteria
Study will include adult patients with end-stage liver disease accepted for liver transplantation.
You may qualify if:
- All adult patients scheduled for liver transplantation will be offered the opportunity to participate in this research.
You may not qualify if:
- Patients unable or unwilling to provide adequate informed consent will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, 17033-0850, United States
Related Publications (1)
Bezinover D, Kadry Z, McCullough P, McQuillan PM, Uemura T, Welker K, Mastro AM, Janicki PK. Release of cytokines and hemodynamic instability during the reperfusion of a liver graft. Liver Transpl. 2011 Mar;17(3):324-30. doi: 10.1002/lt.22227.
PMID: 21384515DERIVED
Biospecimen
Blood samples were obtained. All blood samples were placed on ice and processed with centrifugation. The plasma supernatant was frozen at -80º Celsius.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dmitri Bezinover, MD, PhD
Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 11, 2010
Study Start
August 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
November 24, 2017
Record last verified: 2017-11