Liver CirrhosisCLC-2009NCT00857181
Cytokines and the Risk of Infection in Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients with biopsy proven or clinically evident liver cirrhosis
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Infection, Inflammation, Cytokines
- Medical subject headings
- Liver Cirrhosis, Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver Cirrhosis | Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
Measured: 18 months
Secondary outcomes (4)
All infections
Measured: 18 months
Hospitalisation for reasons other than infection
Measured: 18 months
Duration of hospitalisation
Measured: 18 months
Mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Finding to be unable to reach the primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Stadlbauer-Koellner, MD, Medical University of Graz
- Investigators
- Thomas R. Pieber, MD., Study director, Medical University of GrazVanessa Stadlbauer-Koellner, MD., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857181
- Sponsor's protocol ID
- CLC-2009-01
- Acronym
- CLC-2009
- Status last verified
- Mar 2012
- First submitted
- 5 Mar 2009
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Study to Investigate Cytokine Levels in Patients With Hepatic Cirrhosis Before the Development of Significant Infection
- ClinicalTrials.gov ID
- NCT00857181
- Acronym / sponsor ID
- CLC-2009 / CLC-2009-01
- Conditions
- Liver Cirrhosis
- Keywords
- Liver Cirrhosis, Infection, Inflammation, Cytokines
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Finding to be unable to reach the primary endpoint
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver Cirrhosis | – | –Single cohort of patients with liver cirrhosis to be investigated in the study. Two-monthly measurements of serum cytokines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with biopsy proven or clinically evident liver cirrhosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation.
Time frame: 18 months
4 secondary outcomes
All infections
Time frame: 18 months
Hospitalisation for reasons other than infection
Time frame: 18 months
Duration of hospitalisation
Time frame: 18 months
Mortality
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Finding to be unable to reach the primary endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R. Pieber, MD. study director
Medical University of Graz
Vanessa Stadlbauer-Koellner, MD. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Finding to be unable to reach the primary endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant infection requiring antibiotic, antiviral or antifungal treatment and hospitalisation. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.