- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120743
Correlation Between Release of Cytokines From Liver Graft and Hemodynamic Instability
November 21, 2017 updated by: Penn State University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study will include adult patients with end-stage liver disease accepted for liver transplantation.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
A period of 20 minutes, beginning at the start of reperfusion and continuing until 20 minutes after reperfusion.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dmitri Bezinover, MD, PhD, Penn State Milton S. Hershey Medical Center, Penn State College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
May 3, 2010
First Submitted That Met QC Criteria
May 7, 2010
First Posted (Estimate)
May 11, 2010
Study Record Updates
Last Update Posted (Actual)
November 24, 2017
Last Update Submitted That Met QC Criteria
November 21, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- No 28764
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Transplantation
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCzechia, France, Italy, Poland, United Kingdom
-
The Hospital for Sick ChildrenCompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationCanada
-
Astellas Pharma Europe Ltd.TerminatedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationSpain, Australia, France, Germany, Canada, Italy, United Kingdom, Belgium, South Africa, Switzerland, Sweden, United States, Austria, Brazil, Czechia, Denmark, Finland, Hungary, Ireland, Mexico, Netherlands, New Zealand, Poland
-
Astellas Pharma Europe Ltd.CompletedLiver Transplantation | Kidney Transplantation | Heart TransplantationBelgium, France, Germany, Poland, Spain, United Kingdom
-
Astellas Pharma Europe Ltd.Active, not recruitingLiver Transplantation | Kidney Transplantation | Heart Transplantation | Lung Transplantation | Intestine TransplantationBelgium, Czechia, France, Germany, Italy, Poland, United Kingdom
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingLiver Transplantation | Kidney TransplantationFrance
-
Astellas Pharma China, Inc.CompletedLiver Transplantation | Kidney TransplantationChina
-
Astellas Pharma China, Inc.CompletedLiver Transplantation | Kidney TransplantationChina
-
Rennes University HospitalCompletedLiver Transplantation | Kidney TransplantationFrance