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AGRA Before and After Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03446521
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
The immune system is impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients at risk. It is still unclear, how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections. Therefore, AGRA will be measured before and after liver transplantation and predictive merit of AGRA for post-transplant infections will be tested.

Condition or disease
Liver Cirrhosis

Detailed Description:

Cirrhosis-associated immune dysfunction syndrome (CAIDS) is a well-recognized phenomenon. It affects all immune cells as well as the humoral immune system. Because of this deficiency patients with liver cirrhosis often suffer from severe infections that can be complicated by sepsis, acute renal or liver failure, and lead to prolonged hospitalization and ultimately to the death of the patient. The humoral immune system is a first-line defence mechanism and consists of cell-free molecules that are partly produced by the liver and target pathogens through opsonisation, growth inhibition and lysis. A cirrhotic liver cannot reach its full protein expression capacity and consequently, quantitative and qualitative changes of complement factors and immunoglobulins have been observed in liver disease patients before.

Liver transplantation remains the only curative option to treat liver cirrhosis and its extrahepatic manifestations; however due to limited organ supply this option is not applicable in all cases. Therefore, liver cirrhosis and its complications (eg. infections) need to be managed by health care professionals, who often lack appropriate tools for risk assessment. To meet this clinical need, a novel biomarker was recently established (Acellular Growth Retardation Ability, short AGRA) that uses the state of the humoral immune system to predict the future occurrence of severe infection in liver disease patients. However, it is still unclear how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections.

Therefore, patients scheduled for liver transplantation will be included in the trial. AGRA measurements before and after the transplant (1, 7, 90 days after the end of antibiotic treatment) will be performed. Additionally outcome data regarding severe infections are collected for one year before and after transplantation. The respective organ donors are included as a control group.


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Study Type : Observational
Estimated Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Humoral Immune Status in Patients With Liver Cirrhosis Before and After Liver Transplantation
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Test group
Patients undergoing liver transplantation, no intervention (study-specific) is planed
Control Group
Respective organ donors of the included liver recipients, no intervention (study-specific) is planed



Primary Outcome Measures :
  1. Change of Acellular growth retardation ability (AGRA) [ Time Frame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation ]
    Functional biomarker for the state of the humoral immune system


Secondary Outcome Measures :
  1. Infections [ Time Frame: 1 year after transplantation ]
    Occurrence of severe infections

  2. Infections [ Time Frame: 1 year before transplantation ]
    Occurrence of severe infections

  3. Complications [ Time Frame: during hospital stay ]
    Occurrence of transplantation-related complications

  4. C reactive protein [ Time Frame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation ]
    routine biomarker for infections

  5. Liver function [ Time Frame: before transplantation ]
    State of the donated liver, including results of a possible liver biopsy prior to transplantation


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients listed for liver transplantation at the University Hospital in Graz, Austria for any reason will be included in the study. The respective donors will serve as a control cohort.
Criteria

Inclusion Criteria:

  • Patients between 18-80 years
  • Listed for liver transplantation (for recipients)
  • Liver recipient is included in the study (for donors)
  • Informed consent

Exclusion Criteria:

  • Antibiotic therapy with substances active against E. coli at the scheduled blood sampling

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): NCT03446521


Locations
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Austria
Department of Internal Medicine, Medical University of Geraz Recruiting
Graz, Austria, 8036
Contact: Angela Horvath, PhD    0043 316 385 ext 0    angela.horvath@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03446521     History of Changes
Other Study ID Numbers: AGRA-TX
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases