An observational study in Ascites Hepatic, Liver Failure and Cirrhosis, Liver, sponsored by Carol Davila University of Medicine and Pharmacy. Recruiting at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Carol Davila University of Medicine and Pharmacy · Observational
The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.
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.
190 studies on the registry are indexed under Liver Failure; 33 are open to participants now.
This study's planned enrollment of 30 is below the median of 129 across 66 observational studies indexed under Liver Failure.
Browse Liver Failure studies →Carol Davila University of Medicine and Pharmacy is the lead sponsor of 25 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted with chronic liver failure and ascites. A diagnostic paracentesis will be performed at the day of admission.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Determination of presepsin levels in ascites
A diagnostic paracentesis will be performed and presepsin level will be determined in ascites.
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No
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Carol Davila University of Medicine and Pharmacy