Is routine follow-up paracentesis needed after starting antibiotics for SBP in cirrhosis?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot randomized trial enrolling 40 adults with cirrhosis and SBP to compare routine follow-up paracentesis at 48 hours versus no routine follow-up paracentesis, in addition to standard antibiotics and IV albumin. Participants are randomly assigned 1:1 to either approach and will be treated according to a predefined protocol. The study aims to determine if routine follow-up fluid sampling improves clinical outcomes or if it can be safely omitted when the patient shows clinical improvement. Results could inform whether this procedure is routinely needed to guide care in SBP. Safety monitoring will track adverse events and overall survival.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years or older
* Diagnosis of liver cirrhosis based on clinical, histologic, or imaging findings
* Diagnosis of spontaneous bacterial peritonitis confirmed by an ascitic fluid polymorphonuclear leukocyte (PMN) count of ≥250 cells/mm³ at initial paracentesis
* Ability and willingness to provide written informed consent

Exclusion Criteria:

* Suspected secondary bacterial peritonitis, including suspected perforation of a gastrointestinal organ
* Inability to safely undergo paracentesis, defined as platelet count \<20,000/mm³ or prothrombin time international normalized ratio (PT-INR) \>3.0
* Active bleeding or shock
* Expected survival of less than 48 hours
* Pregnancy or breastfeeding
* Previous ascitic fluid or blood culture demonstrating resistance to cefotaxime or ceftriaxone
* Any other condition that, in the investigator's judgment, would prevent adherence to the study protocol

Where it's running

• Chonnam National University Hospital
  Gwangju, Gwangju, South Korea Recruiting

Study contacts

• Study coordinator: Eun-chae Yoo, CRC(Clinical research coordinator)
• Email: karenaec5@daum.net
• Phone: +82-62-220-6216

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.