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Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120743
First Posted: May 11, 2010
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Penn State University
  Purpose
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.

Condition
Liver Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Stability During Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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. [ Time Frame: A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion. ]
    Cytokines released from the liver graft could be a cause for negative inotropy and systemic vasodilatation.


Secondary Outcome Measures:
  • Correlation between the level of cytokines and hemodynamic stability during reperfusion. [ Time Frame: A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion. ]
    First 20 minutes after liver graft reperfusion is a time of maximal hemodynamic instability. A correlation between the level of cytokines and hemodynamic instability could be important for understanding of this condition


Biospecimen Retention:   Samples Without DNA
Blood samples were obtained. All blood samples were placed on ice and processed with centrifugation. The plasma supernatant was frozen at -80º Celsius.

Enrollment: 17
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:
Reperfusion of the graft is the most critical part of liver transplantation because of the difficulties in managing the resulting severe hemodynamic instability. The patients who are accepted to be listed for liver transplantation undergo evaluation of their cardiac function and are usually relatively stable with, at most, minimal cardiac problems (a requirement for inclusion in the liver transplantation program). Additionally, we observe completely unpredictable hemodynamic reactions during and after the graft reperfusion, requiring vastly different doses of catecholamine in order to maintain an acceptable level of perfusion pressure. The adverse cardiopulmonary effects are thought to be associated with the preexisting level of various proinflammatory factors, including cytokines (TNF-alpha, IL-6) and proinflammatory phospholipase A2 (sPLA2) produced in the graft as a reaction to the conservation solution and cold temperature (necessary to keep the organ capable for transplantation) and released into the bloodstream during reperfusion. The massive release of cytokines after unclamping of the graft may be responsible for negative inotropy and significant vasodilatation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study will include adult patients with end-stage liver disease accepted for liver transplantation.
Criteria

Inclusion Criteria:

  • All adult patients scheduled for liver transplantation will be offered the opportunity to participate in this research.

Exclusion Criteria:

  • Patients unable or unwilling to provide adequate informed consent will be excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120743


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Dmitri Bezinover, MD, PhD Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT01120743     History of Changes
Other Study ID Numbers: No 28764
First Submitted: May 3, 2010
First Posted: May 11, 2010
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Penn State University:
liver failure
cytokines
hemodynamic instability