Clinical trial NCT06224023: Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure
Official title: Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ascites Hepatic
Liver Failure
Cirrhosis, Liver
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Mortality at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Spontaneous bacterial peritonitis (SBP) rate
timeFrame: 6 months
measure: Hepatic encephalopathy rate
timeFrame: 6 months
measure: Any infection rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Agrippa Ionescu" Hospital
Study officials:
References:
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.
citation: 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.