Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure

Cirrhosis, Liver Clinical Trial

— PASS  

Official title:

Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224023
• Other study ID #: PASS
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Cirrhosis, Liver
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Failure

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