Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Randomized Controlled Study of Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis in Liver Cirrhosis: A Pilot Study
Spontaneous bacterial peritonitis (SBP) is a serious infection that occurs in patients with liver cirrhosis and ascites and is associated with substantial morbidity and mortality. Current clinical practice often includes follow-up paracentesis approximately 48 hours after starting antibiotic treatment to assess the change in the ascitic fluid polymorphonuclear leukocyte (PMN) count. However, it remains uncertain whether routine follow-up paracentesis improves clinical outcomes compared with a strategy based primarily on clinical response.
This pilot randomized controlled trial will evaluate whether routine follow-up paracentesis is necessary in patients with cirrhosis and SBP. A total of 40 adult patients with SBP will be randomly assigned in a 1:1 ratio to either a routine follow-up paracentesis group or a no-routine follow-up paracentesis group. All participants will receive standard antibiotic therapy and intravenous albumin according to the study protocol.
Participants assigned to the routine follow-up paracentesis group will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy. Ascitic fluid PMN counts and other laboratory findings will be assessed, and antibiotic treatment may be modified according to the treatment response. Participants assigned to the no-routine follow-up paracentesis group will be monitored using clinical symptoms, vital signs, and blood inflammatory markers without scheduled repeat paracentesis. However, paracentesis may be performed at any time if clinically indicated, such as in the presence of worsening abdominal symptoms, persistent fever, or hemodynamic instability.
The study will compare clinical outcomes between the two treatment strategies, including 30-day and 90-day survival, treatment response, duration of antibiotic therapy, length of hospital stay, SBP recurrence, complications, new infections, and medical costs. The results of this pilot study are intended to provide preliminary evidence for determining whether routine follow-up paracentesis can be safely avoided in selected patients with SBP and to inform the design of a larger randomized controlled trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eun-chae Yoo, CRC(Clinical research coordinator)
- Numéro de téléphone: +82-62-220-6216
- E-mail: karenaec5@daum.net
Lieux d'étude
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Gwangju
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Gwangju, Gwangju, Corée du Sud, 61469
- Recrutement
- Chonnam National University Hospital
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Contact:
- Jae Hyun Yoon, Assistant Professor, M.D., Ph.D.
- Numéro de téléphone: +82-62-220-6216
- E-mail: zenmake14@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: A (Routine Follow-up Paracentesis)
Routine follow-up paracentesis approximately 48 hours after initiation of antibiotic therapy. |
Participants assigned to the routine follow-up paracentesis arm will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy for spontaneous bacterial peritonitis. Ascitic fluid will be analyzed for polymorphonuclear leukocyte (PMN) count, bacterial culture and antimicrobial susceptibility, and biochemical parameters. If the ascitic fluid PMN count has not decreased by at least 25% from baseline, antibiotic therapy may be escalated according to the study protocol. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. |
|
Comparateur actif: B (No Routine Follow-up Paracentesis)
No routine follow-up paracentesis; paracentesis will be performed only when clinically indicated. |
Participants will not undergo scheduled follow-up paracentesis at approximately 48 hours. Treatment response will be assessed based on clinical symptoms, vital signs, and blood inflammatory markers. Paracentesis may be performed if clinically indicated, such as for worsening abdominal symptoms, persistent fever, or hemodynamic instability. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
30 Day Overall Survival
Délai: 30 days after randomization
|
The proportion of participants who are alive at 30 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge. |
30 days after randomization
|
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90 Day Overall Survival
Délai: 90 days after randomization
|
The proportion of participants who are alive at 90 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge. |
90 days after randomization
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Length of Hospital Stay
Délai: From hospital admission to discharge, assessed up to 90 days
|
Total number of days from hospital admission to discharge. |
From hospital admission to discharge, assessed up to 90 days
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Antibiotic-Related Adverse Events
Délai: Through index hospital discharge, assessed up to 90 days
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The proportion of participants experiencing antibiotic-related adverse events, including Clostridioides difficile-associated diarrhea, drug allergy, or anaphylaxis. |
Through index hospital discharge, assessed up to 90 days
|
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Duration of Antibiotic Therapy
Délai: From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
|
Total number of days of systemic antibiotic treatment administered for spontaneous bacterial peritonitis during the index hospitalization. |
From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
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Recurrence of Spontaneous Bacterial Peritonitis
Délai: Up to 90 days after randomization
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The proportion of participants who develop recurrent spontaneous bacterial peritonitis within 90 days after randomization. |
Up to 90 days after randomization
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New Infection During Hospitalization
Délai: Through index hospital discharge, assessed up to 90 days
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The proportion of participants who develop a new infection other than the initial episode of spontaneous bacterial peritonitis during the index hospitalization. |
Through index hospital discharge, assessed up to 90 days
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Cirrhosis-Related Complications
Délai: Up to 90 days after randomization
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The proportion of participants who develop major cirrhosis-related complications, including hepatorenal syndrome or clinically significant bleeding, during follow-up. |
Up to 90 days after randomization
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Medical Costs
Délai: Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
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Total medical costs incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care. |
Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CNUH-2026-313
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
Informations sur les médicaments et les dispositifs, documents d'étude
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