Cytokines and the Risk of Infection in Liver Cirrhosis (CLC-2009)
The aim of this study is to test whether the oscillation of cytokine concentrations in serum is able to predict the development of infection in patients with liver cirrhosis.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection|
- Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- All infections [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Hospitalisation for reasons other than infection [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Duration of hospitalisation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Serum and plasma samples.
|Study Start Date:||March 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines.
Patients with liver cirrhosis frequently develop bacterial, viral or fungal infections which are the main trigger for decompensation of cirrhosis and development of complications and thereby infection hugely impacts morbidity and mortality in these patients. However, there is no clinical test available that allows rapid, on-site decision making if a patient is likely to develop an infection. The purpose of this study is to measure cytokines interleukin (IL) 6, IL8, IL10 and TNFalpha in patients with liver cirrhosis over a long follow-up period and test whether these inflammatory markers are able to predict the occurrence of infection before it becomes clinically significant. For this purpose, one hundred fifty consecutive patients with diagnosis of liver cirrhosis will be followed bi-monthly for 18 months. Blood samples will be collected for the cytokine measurements and infection cases will be reported at each study visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857181
|Medical University Graz|
|Graz, Steiermark, Austria, 8036|
|Study Director:||Thomas R. Pieber, MD.||Medical University of Graz|
|Principal Investigator:||Vanessa Stadlbauer-Koellner, MD.||Medical University of Graz|