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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06224023
Other study ID # PASS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 6, 2024
Est. completion date June 2024

Study information

Verified date May 2024
Source Carol Davila University of Medicine and Pharmacy
Contact Mihai Ciocirlan
Phone 0040722322625
Email ciocirlanm@yahho.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patient with ascites and chronic liver failure - no contraindications and technical possibility to perform diagnostic paracentesis - age above 18 years old - informed consent Exclusion Criteria: - contraindications to paracentesis or technical impossibility to perform paracentesis - absence of informed consent

Study Design


Intervention

Diagnostic Test:
Determination of presepsin levels in ascites
A diagnostic paracentesis will be performed and presepsin level will be determined in ascites.

Locations

Country Name City State
Romania "Agrippa Ionescu" Hospital Bucharest

Sponsors (1)

Lead Sponsor Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (2)

Ferrarese 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
6 months
Secondary 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. 6 months
Secondary 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.
6 months
Secondary 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.
6 months
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