Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03446521

AGRA Before and After Liver Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Medical University of Geraz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Feb 26, 2018
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.