Cytokines and the Risk of Infection in Liver Cirrhosis | NCT00857181

Studies
Cytokines and the Risk of Infection in Liver Cirrhosis

NCT00857181

Sponsor

Medical University of Graz

Status

Terminated

Last Update Posted

Mar 5, 2012Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Liver Cirrhosis

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Finding to be unable to reach the primary endpoint

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 5, 2009

First Posted Date

Mar 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

150 patients with biopsy proven or clinically evident liver cirrhosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas R. Pieber, MD.	Medical University of Graz	Study Director
Vanessa Stadlbauer-Koellner, MD.	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Graz		Graz	Styria	8036	Austria

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D007239	Infections
D007249	Inflammation

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

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