AGRA Before and After Liver Transplantation

Liver Cirrhosis Clinical Trial

Official title:

Humoral Immune Status in Patients With Liver Cirrhosis Before and After Liver Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03446521
• Other study ID #: AGRA-TX
• Status: Active, not recruiting
• Start date: July 6, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Austria	Department of Internal Medicine, Medical University of Geraz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Acellular growth retardation ability (AGRA)	Functional biomarker for the state of the humoral immune system	change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Secondary	Infections	Occurrence of severe infections	1 year after transplantation
Secondary	Infections	Occurrence of severe infections	1 year before transplantation
Secondary	Complications	Occurrence of transplantation-related complications	during hospital stay
Secondary	C reactive protein	routine biomarker for infections	change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation
Secondary	Liver function	State of the donated liver, including results of a possible liver biopsy prior to transplantation	before transplantation