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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Eun-chae Yoo, CRC(Clinical research coordinator)
- Número de telefone: +82-62-220-6216
- E-mail: karenaec5@daum.net
Locais de estudo
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Gwangju
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Gwangju, Gwangju, Coréia do Sul, 61469
- Recrutamento
- Chonnam National University Hospital
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Contato:
- Jae Hyun Yoon, Assistant Professor, M.D., Ph.D.
- Número de telefone: +82-62-220-6216
- E-mail: zenmake14@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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30 Day Overall Survival
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Length of Hospital Stay
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CNUH-2026-313
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
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