Clinical trial NCT03446521: AGRA Before and After Liver Transplantation
Official title: Humoral Immune Status in Patients With Liver Cirrhosis Before and After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change of Acellular growth retardation ability (AGRA)
timeFrame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Secondary outcomes:
measure: Infections
timeFrame: 1 year after transplantation
measure: Infections
timeFrame: 1 year before transplantation
measure: Complications
timeFrame: during hospital stay
measure: C reactive protein
timeFrame: change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
measure: Liver function
timeFrame: before transplantation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Medical University of Geraz
Study officials:
References: