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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857181
Recruitment Status : Terminated (Finding to be unable to reach the primary endpoint)
First Posted : March 6, 2009
Last Update Posted : March 5, 2012
Information provided by (Responsible Party):
Vanessa Stadlbauer-Koellner, MD, Medical University of Graz

Brief 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.

Condition or disease
Liver Cirrhosis

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
Actual Enrollment : 150 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. All infections [ Time Frame: 18 months ]
  2. Hospitalisation for reasons other than infection [ Time Frame: 18 months ]
  3. Duration of hospitalisation [ Time Frame: 18 months ]
  4. Mortality [ Time Frame: 18 months ]

Biospecimen Retention:   Samples Without DNA
Serum and plasma samples.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 patients with biopsy proven or clinically evident liver cirrhosis

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857181

Medical University Graz
Graz, Steiermark, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Study Director: Thomas R. Pieber, MD. Medical University of Graz
Principal Investigator: Vanessa Stadlbauer-Koellner, MD. Medical University of Graz

Responsible Party: Vanessa Stadlbauer-Koellner, MD, MD, Medical University of Graz Identifier: NCT00857181     History of Changes
Other Study ID Numbers: CLC-2009-01
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Vanessa Stadlbauer-Koellner, MD, Medical University of Graz:
Liver Cirrhosis

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases