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

This study has been terminated.
(Finding to be unable to reach the primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00857181
First received: March 5, 2009
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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
Liver Cirrhosis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liver Cirrhosis
Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

150 patients with biopsy proven or clinically evident liver cirrhosis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857181

Locations
Austria
Medical University Graz
Graz, Steiermark, Austria, 8036
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Vanessa Stadlbauer-Koellner, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00857181     History of Changes
Other Study ID Numbers: CLC-2009-01
Study First Received: March 5, 2009
Last Updated: March 2, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Liver Cirrhosis
Infection
Inflammation
Cytokines

Additional relevant MeSH terms:
Infection
Liver Cirrhosis
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 23, 2014