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

NCT06224023 | Recruiting

• 1 other identifier: PASS
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ascites Hepatic; Liver Failure; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Spontaneous bacterial peritonitis (SBP) rate

  6 months

• Hepatic encephalopathy rate

  6 months

• Any infection rate

  6 months

Study Arms (1)

Patients with chronic liver failure and ascites

Diagnostic Test: Determination of presepsin levels in ascites

Interventions

Determination of presepsin levels in ascites DIAGNOSTIC_TEST

A diagnostic paracentesis will be performed and presepsin level will be determined in ascites.

Patients with chronic liver failure and ascites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• patient with ascites and chronic liver failure
• no contraindications and technical possibility to perform diagnostic paracentesis
• age above 18 years old
• informed consent

You may not qualify if:

• contraindications to paracentesis or technical impossibility to perform paracentesis
• absence of informed consent

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

"Agrippa Ionescu" Hospital

Bucharest, Romania

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ascites, peripheral blood

MeSH Terms

Conditions

Liver Failure; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mihai Ciocirlan

CONTACT

0040722322625; ciocirlanm@yahho.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 25, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)