Clinical trial NCT00857181: Cytokines and the Risk of Infection in Liver Cirrhosis
Official title: A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
Infection
Inflammation
Cytokines
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2009-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with biopsy proven or clinically evident liver cirrhosis

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
timeFrame: 18 months
Secondary outcomes:
measure: All infections
timeFrame: 18 months
measure: Hospitalisation for reasons other than infection
timeFrame: 18 months
measure: Duration of hospitalisation
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Steiermark
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, MD.
role: STUDY_DIRECTOR
affiliation: Medical University of Graz
name: Vanessa Stadlbauer-Koellner, MD.
role: PRINCIPAL_INVESTIGATOR
References: