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

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

Study Overview

• Status: Recruiting
• Conditions: Liver Failure; Cirrhosis, Liver; Ascites Hepatic
• Intervention / Treatment: Diagnostic test: Determination of presepsin levels in ascites

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Mihai Ciocirlan; Phone Number: 0040722322625; Email: ciocirlanm@yahho.com

Study Locations

• Romania
  • Bucharest, Romania
    • Recruiting
    • "Agrippa Ionescu" Hospital
    • Contact: Mihai L Ciocirlan; Phone Number: 0040722322625; Email: mihai.ciocirlan@umfcd.ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted with chronic liver failure and ascites. A diagnostic paracentesis will be performed at the day of admission.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with chronic liver failure and ascites	Diagnostic test: Determination of presepsin levels in ascites; A diagnostic paracentesis will be performed and presepsin level will be determined in ascites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Liver Cirrhosis; Ascites
• Other Study ID Numbers: PASS (Other)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No