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NCT Number: NCT06224023

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

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

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Key information

Conditions

Ascites Hepatic Cirrhosis, Liver Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determination of presepsin levels in ascites

Diagnostic Test

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

Primary outcomes

  1. Mortality at 6 months

    Time frame: 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 outcomes

  1. Spontaneous bacterial peritonitis (SBP) rate

    Time frame: 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.

  2. Hepatic encephalopathy rate

    Time frame: 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.

  3. Any infection rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mihai Ciocirlan

CONTACT

[email protected]

0040722322625

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Acronym: PASS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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