Cytokines and the Risk of Infection in Liver Cirrhosis

NCT00857181 | Terminated

• 1 other identifier: CLC-2009-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; Infection; Inflammation; Cytokines

Outcome Measures

Primary Outcomes (1)

• Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.

  18 months

Secondary Outcomes (4)

• All infections

  18 months

• Hospitalisation for reasons other than infection

  18 months

• Duration of hospitalisation

  18 months

• Mortality

  18 months

Study Arms (1)

Liver Cirrhosis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients with biopsy proven or clinically evident liver cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples.

MeSH Terms

Conditions

Liver Cirrhosis; Infections; Inflammation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas R. Pieber, MD.

  Medical University of Graz

  STUDY DIRECTOR

• Vanessa Stadlbauer-Koellner, MD.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

AU (1)