Ascites HepaticPASSNCT06224023
Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure
An observational study of Ascites Hepatic and Liver Failure, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites Hepatic, Liver Failure, Cirrhosis, Liver
- What is being tested?
- Determination of presepsin levels in ascites
- How many people
- 30 participants
- Where
- 1 siteRomania
- Study dates
- 1 Aug 2024to 31 Dec 2024
- 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: Adult patients admitted with chronic liver failure and ascites. A diagnostic paracentesis will be performed at the day of admission.
Who may be able to join
- patient with ascites and chronic liver failure
- no contraindications and technical possibility to perform diagnostic paracentesis
- age above 18 years old
- informed consent
Who cannot join
- contraindications to paracentesis or technical impossibility to perform paracentesis
- absence of informed consent
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
"Agrippa Ionescu" Hospital
Bucharest
Mihai L Ciocirlan, 0040722322625, mihai.ciocirlan@umfcd.ro
About this study
The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.
Read the detailed description
Presepsin is a plasmatic cleaved fragment of CD14. CD14 is a toll like receptor who has the role to identify certain lipopolysaccharides on the surface of bacteria (aerobes and anaerobes), thus promoting an inflammatory response.
A study of 153 patients with liver cirrhosis published by a team of investigators from Iasi, Romania, has proven an useful role of plasma presepsin in early diagnosis of infections in patients in acute on chronic liver failure.
In addition, plasma presepsin has been proposed as an independent predictor of mortality in patients with decompensated liver cirrhosis, without concomitant bacterial infections.
Question to be answered by this study The investigators aim to evaluate the predictive role of ascites presepsin in patients with chronic liver failure.
Hypothesis Presepsin levels in ascites may have a prognostic role in patients with ascites and chronic liver failure.
- Conditions
- Ascites Hepatic, Liver Failure, Cirrhosis, Liver
- Being tested
- Determination of presepsin levels in ascites
- Medical subject headings
- Liver Failure, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of presepsin levels in ascitesDiagnostic test
A diagnostic paracentesis will be performed and presepsin level will be determined in ascites.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic liver failure and ascites | Not described Receives: Diagnostic Test: Determination of presepsin levels in ascites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 6 months
Number of who deceased during admission or during the 180 days after admission divided by the number of patients who were admitted.
An analysis will be done to see if the presepsin levels are predictive for this event.
Measured: 6 months
Secondary outcomes (3)
Spontaneous bacterial peritonitis (SBP) rate
The number of patients diagnosed with SBP during admission divided by the total number of patients. An analysis will be done to see if the presepsin levels are predictive for this event.
Measured: 6 months
Hepatic encephalopathy rate
Number of patients diagnosed with hepatic encephalopathy during admission divided by the total number of patients.
An analysis will be done to see if the presepsin levels are predictive for this event.
Measured: 6 months
Any infection rate
The number of patients diagnosed with any infection during admission divided by the total number of patients.
An analysis will be done to see if the presepsin levels are predictive for this event.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ascites HepaticStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224023
- Sponsor's protocol ID
- PASS
- Acronym
- PASS
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Igna R, Girleanu I, Cojocariu C, Huiban L, Muzica C, Singeap AM, Sfarti C, Chiriac S, Petrea OC, Zenovia S, Nastasa R, Cuciureanu T, Stafie R, Stratina E, Rotaru A, Stanciu C, Blaj M, Trifan A. The Role of Presepsin and Procalcitonin in Early Diagnosis of Bacterial Infections in Cirrhotic Patients with Acute-on-Chronic Liver Failure. J Clin Med. 2022 Sep 15;11(18):5410. doi: 10.3390/jcm11185410.
PubMed 36143057Ferrarese A, Plebani M, Frigo AC, Burra P, Senzolo M. Presepsin as a biomarker of inflammation and prognosis in decompensated liver disease. J Hepatol. 2021 Jul;75(1):232-234. doi: 10.1016/j.jhep.2021.01.016. Epub 2021 Jan 21. No abstract available.
PubMed 33484772
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT06224023
- Acronym / sponsor ID
- PASS / PASS
- Conditions
- Ascites Hepatic, Liver Failure, Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jan 2024 (actual)
- 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 investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.
Detailed description
Presepsin is a plasmatic cleaved fragment of CD14. CD14 is a toll like receptor who has the role to identify certain lipopolysaccharides on the surface of bacteria (aerobes and anaerobes), thus promoting an inflammatory response.
A study of 153 patients with liver cirrhosis published by a team of investigators from Iasi, Romania, has proven an useful role of plasma presepsin in early diagnosis of infections in patients in acute on chronic liver failure.
In addition, plasma presepsin has been proposed as an independent predictor of mortality in patients with decompensated liver cirrhosis, without concomitant bacterial infections.
Question to be answered by this study The investigators aim to evaluate the predictive role of ascites presepsin in patients with chronic liver failure.
Hypothesis Presepsin levels in ascites may have a prognostic role in patients with ascites and chronic liver failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic liver failure and ascites | – | Diagnostic Test: Determination of presepsin levels in ascites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted with chronic liver failure and ascites. A diagnostic paracentesis will be performed at the day of admission.
Key inclusion criteria (4 listed)
- patient with ascites and chronic liver failure
- no contraindications and technical possibility to perform diagnostic paracentesis
- age above 18 years old
- informed consent
Key exclusion criteria (2 listed)
- contraindications to paracentesis or technical impossibility to perform paracentesis
- absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determination of presepsin levels in ascitesA diagnostic paracentesis will be performed and presepsin level will be determined in ascites. | Diagnostic test | Patients with chronic liver failure and ascites |
Primary outcome
Mortality at 6 months
Time frame: 6 months
Number of who deceased during admission or during the 180 days after admission divided by the number of patients who were admitted. An analysis will be done to see if the presepsin levels are predictive for this event.
3 secondary outcomes
Spontaneous bacterial peritonitis (SBP) rate
Time frame: 6 months
Hepatic encephalopathy rate
Time frame: 6 months
Any infection rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 36143057Igna R, Girleanu I, Cojocariu C, Huiban L, Muzica C, Singeap AM, Sfarti C, Chiriac S, Petrea OC, Zenovia S, Nastasa R, Cuciureanu T, Stafie R, Stratina E, Rotaru A, Stanciu C, Blaj M, Trifan A. The Role of Presepsin and Procalcitonin in Early Diagnosis of Bacterial Infections in Cirrhotic Patients with Acute-on-Chronic Liver Failure. J Clin Med. 2022 Sep 15;11(18):5410. doi: 10.3390/jcm11185410.
- Background: PubMed 33484772Ferrarese A, Plebani M, Frigo AC, Burra P, Senzolo M. Presepsin as a biomarker of inflammation and prognosis in decompensated liver disease. J Hepatol. 2021 Jul;75(1):232-234. doi: 10.1016/j.jhep.2021.01.016. Epub 2021 Jan 21. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 Ascites Hepatic and Liver Failure, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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 Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihai Ciocirlan (0040722322625, ciocirlanm@yahho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06224023, which also lists 2 linked publications.
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 21 Aug 2024.