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Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability

This study has been completed.
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01120743
First received: May 3, 2010
Last updated: May 7, 2010
Last verified: July 2009

May 3, 2010
May 7, 2010
August 2008
April 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Cytokines released from the liver graft could be a cause for negative inotropy and systemic vasodilatation.
Same as current
Complete list of historical versions of study NCT01120743 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability
Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Stability During Liver Transplantation

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples were obtained. All blood samples were placed on ice and processed with centrifugation. The plasma supernatant was frozen at -80º Celsius.

Non-Probability Sample

Study will include adult patients with end-stage liver disease accepted for liver transplantation.

Liver Transplantation
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120743
No 28764
No
Dmitri Bezinover Assistant Professor of Anesthesiology, Penn State Milton S. Hershey Medical Center
Penn State University
Not Provided
Principal Investigator: Dmitri Bezinover, MD, PhD Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
Penn State University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP