CirrhosisNCT01578226
Procalcitonin in Cirrhotic Patients at High Risk for Sepsis
An observational study of Cirrhosis and Ascites, run by Prof. Facchinetti Fabio at 1 site in Italy.
Trial summary
Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Sep 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ascitic cirrhotic patients admitted to our third level Liver Unit.
Who may be able to join
- liver cirrhosis regardless of aetiology
- clinically relevant ascitic decompensation at time of hospital admission
Who cannot join
- high haematic ascites
- ongoing antimicrobial therapy or stopped less than 7 days before admission
- last hospital discharge within 7 days
- surgery or trauma within 30 days from enrolment
- hepatocellular carcinoma out of Milan criteria
- extra hepatic malignancies
- immunodeficiency syndrome
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients
Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.
- Keywords
- Cirrhosis, Ascites, Decompensation, Bacterial infection, Sepsis, Procalcitonin, PCT
- Medical subject headings
- Fibrosis, Ascites, Sepsis, Bacterial Infections
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 |
|---|---|---|
| Decompensated cirrhotic patients | Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Facchinetti Fabio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
- Investigators
- Filippo Schepis, MD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578226
- Sponsor's protocol ID
- PCTCIRR
- Status last verified
- Apr 2012
- First submitted
- 13 Apr 2012
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Procalcitonin (PCT) for the Diagnosis of Sepsis in Ascitic Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT01578226
- Acronym / sponsor ID
- PCTCIRR
- Keywords
- Cirrhosis, Ascites, Decompensation, Bacterial infection, Sepsis, Procalcitonin, PCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Prof. Facchinetti FabioUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Apr 2012 (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.
Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompensated cirrhotic patients | – | –Cirrhotic patients presenting with clinically detectable ascites (Grade 2 o Grade 3) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ascitic cirrhotic patients admitted to our third level Liver Unit.
Key inclusion criteria (2 listed)
- liver cirrhosis regardless of aetiology
- clinically relevant ascitic decompensation at time of hospital admission
Key exclusion criteria (8 listed)
- high haematic ascites
- ongoing antimicrobial therapy or stopped less than 7 days before admission
- last hospital discharge within 7 days
- surgery or trauma within 30 days from enrolment
- hepatocellular carcinoma out of Milan criteria
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
Filippo Schepis, MD principal investigator
University of Modena and Reggio Emilia
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 Cirrhosis and Ascites, run by Prof. Facchinetti Fabio at 1 site in Italy.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 16 Apr 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 16 Apr 2012.