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Completed

NCT Number: NCT01120743

Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn State Milton S. Hershey Medical Center, Penn State College of Medicine

Hershey, Pennsylvania, 17033-0850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

    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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Stability During Liver Transplantation

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 11, 2010
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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