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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Eun-chae Yoo, CRC(Clinical research coordinator)
- Número de teléfono: +82-62-220-6216
- Correo electrónico: karenaec5@daum.net
Ubicaciones de estudio
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Gwangju
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Gwangju, Gwangju, Corea del Sur, 61469
- Reclutamiento
- Chonnam National University Hospital
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Contacto:
- Jae Hyun Yoon, Assistant Professor, M.D., Ph.D.
- Número de teléfono: +82-62-220-6216
- Correo electrónico: zenmake14@gmail.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: 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. |
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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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30 Day Overall Survival
Periodo de tiempo: 30 days after randomization
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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
Periodo de tiempo: 90 days after randomization
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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
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of Hospital Stay
Periodo de tiempo: From hospital admission to discharge, assessed up to 90 days
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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
Periodo de tiempo: 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
Periodo de tiempo: From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- CNUH-2026-313
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
Información sobre medicamentos y dispositivos, documentos del estudio
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