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Recruiting NCT06224023

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

Observational Ascites Hepatic Liver Failure Cirrhosis, Liver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Determination of presepsin levels in ascites.
Who it may be relevant to
Registry conditions: Ascites Hepatic, Liver Failure, Cirrhosis, Liver. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Romania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Mortality at 6 months [Time frame: 6 months]
Secondary outcome measures (3)
  • Spontaneous bacterial peritonitis (SBP) rate [Time frame: 6 months]
  • Hepatic encephalopathy rate [Time frame: 6 months]
  • Any infection rate [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Romania · 1 center
  • "Agrippa Ionescu" Hospital — Bucharest

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. PMID 36143057
  • 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. PMID 33484772

Identifiers

NCT: NCT06224023 · PASS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗