Cytokines and the Risk of Infection in Liver Cirrhosis (CLC-2009)

March 2, 2012 updated by: Vanessa Stadlbauer-Koellner, MD, Medical University of Graz

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

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 Overview

Status

Terminated

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

150 patients with biopsy proven or clinically evident liver cirrhosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Liver Cirrhosis
Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 18 months
18 months
All infections
Time Frame: 18 months
18 months
Hospitalisation for reasons other than infection
Time Frame: 18 months
18 months
Duration of hospitalisation
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Study Director: Thomas R. Pieber, MD., Medical University of Graz
  • Principal Investigator: Vanessa Stadlbauer-Koellner, MD., Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 2, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLC-2009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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