AGRA Before and After Liver Transplantation
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Change of Acellular growth retardation ability (AGRA) [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
- Infections [1 year after transplantation]
Occurrence of severe infections
- Infections [1 year before transplantation]
Occurrence of severe infections
- Complications [during hospital stay]
Occurrence of transplantation-related complications
- C reactive protein [change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation]
routine biomarker for infections
- Liver function [before transplantation]
State of the donated liver, including results of a possible liver biopsy prior to transplantation
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Internal Medicine, Medical University of Geraz | Graz | Austria | 8036 |
Sponsors and Collaborators
- Medical University of Graz
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AGRA-TX