Cytokines and the Risk of Infection in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— CLC-2009  

Official title:

A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00857181
• Other study ID #: CLC-2009-01
• Status: Terminated
• Phase: N/A
• First received: March 5, 2009
• Last updated: March 2, 2012
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with clinical, radiological and/or histological evidence of liver cirrhosis

• Age above 18 (inclusive) at the time of screening

• Able and willing to give written informed consent and to comply with the requirements of the study

Exclusion Criteria:

• Infection during the last 14 days before screening

• Gastrointestinal bleeding within the last 14 days before screening

• Antibiotic therapy at the time of screening (except prophylaxis of spontaneous bacterial peritonitis)

• Shock or cardiac failure requiring inotrope treatment at the time of screening

• Hepatic encephalopathy grade >2

• Findings suggestive of organic nephropathy or a serum creatinine level of more than 2 mg/dl

• Human immunodeficiency virus infection at time of inclusion

• Use of immunomodulating agents within one month prior to screening (e.g. steroids)

• Any disease (e.g., advanced neoplasia) that could affect the short-term prognosis

• Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cirrhosis

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Steiermark

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	Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.		18 months	No
Secondary	All infections		18 months	No
Secondary	Hospitalisation for reasons other than infection		18 months	No
Secondary	Duration of hospitalisation		18 months	No
Secondary	Mortality		18 months	No