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

Recruiting

• Conditions: Cirrhosis, Liver; Liver Failure; Ascites Hepatic
• Interventions: Diagnostic Test: Determination of presepsin levels in ascites

• Registration Number: NCT06224023
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

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 Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-01-25
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chronic liver failure and ascites	Determination of presepsin levels in ascites	-

Primary Outcome Measures

Name	Time	Method
Mortality at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Spontaneous bacterial peritonitis (SBP) rate	6 months	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.
Hepatic encephalopathy rate	6 months	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.
Any infection rate	6 months	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.

Trial Locations

Locations (1)

"Agrippa Ionescu" Hospital; 🇷🇴 Bucharest, Romania