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
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||108 participants|
|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|
Patients undergoing liver transplantation, no intervention (study-specific) is planed
Respective organ donors of the included liver recipients, no intervention (study-specific) is planed
- 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
- Infections [ Time Frame: 1 year after transplantation ]Occurrence of severe infections
- Infections [ Time Frame: 1 year before transplantation ]Occurrence of severe infections
- Complications [ Time Frame: during hospital stay ]Occurrence of transplantation-related complications
- 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
- 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
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
|Department of Internal Medicine, Medical University of Geraz||Recruiting|
|Graz, Austria, 8036|
|Contact: Angela Horvath, PhD 0043 316 385 ext 0 firstname.lastname@example.org|