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NCT Number: NCT06679842

Early Ascitis Parencentesis in SBP

Paracentesis at 48 hours, as recommended in international guidelines, could delay the time to effective antibiotic therapy in cases of SBP with germs resistant to empirical antibiotic therapy. Earlier paracentesis at 24 hours could save time in initiating the right antibiotic therapy and improve prognosis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatology Unit, CHU Besancon

Besançon, Doubs, 25000, France

About this study

International recommendations call for exploratory paracentesis to be performed on admission in all cirrhotic patients presenting with clinical ascites. Based on data from a study published in 1990, the diagnosis of spontaneous bacterial infection (SBP) is defined by the presence of neutrophils (PNN) ≥ 250/mm3 in ascites fluid, irrespective of the bacteriological culture result . Although culture of ascites fluid is negative in 40-60% of confirmed cases of ISLA, and it takes 2-5 days to obtain a result, it remains essential to best adapt antibiotic therapy. Empirical antibiotic therapy is started as soon as SBP is diagnosed. Response to antibiotic therapy is defined as a reduction of more than 25% in the number of PNN in ascites sampled 48 hours after initiation of treatment. However, the landmark study by Akriviadis et al showed that the mean number of PNN fell significantly as early as 24 hours after the start of treatment, with a drop in PNN as early as the 6th hour. In the absence of a response to treatment, antibiotic therapy should be modified on the basis of culture results if positive, or empirically in the absence of bacteriological documentation. A recent study showed that a reduction in the number of PNN in ascites fluid after effective empirical antibiotic therapy was significantly associated with improved survival. Thus, waiting 48 hours to perform a follow-up paracentesis could delay the adjustment of effective antibiotic therapy in the event of initial non-response, and thus worsen the prognosis of SBP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged 18 or over
  • Affiliation with a French social security
  • Signature of the informed consent form
  • Cirrhosis
  • Ascites fluid infection with PNN > 250/mm3

Exclusion criteria

  • Pregnant women
  • Persons deprived of their liberty by judicial or administrative decision; persons under psychiatric care.
  • Adults under legal protection
  • Subjects within the exclusion period of another study
  • Other cause of abdominal infection than SBP
  • Intra-abdominal surgery < 4 weeks

Treatment and study plan

ascitis paracentesis

Diagnostic Test

ascitis paracentesis

Primary outcomes

  1. Evaluate the percentage drop in neutrophils in ascites on Day 1

    Time frame: 24 hours

    Evaluate the percentage drop in neutrophils in ascites on Day 1, in order to assess the best threshold for predicting response to antibiotic therapy on Day 1 (judged on Day 2) in patients with ascites fluid infection.

Study contacts

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

Jean Paul CERVONI, Hospital Practioner

CONTACT

[email protected]

+33 3 81 66 80 20

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Early Ascitis Parencentesis at Day-1 to Assess Antibiotic Response in Spontaneous Bacterial Peritonitis

Acronym: PAPISLA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Nov 8, 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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