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临床试验/NCT03362632
NCT03362632Unknown不适用

A Prospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIP Study)

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Complete response rate to empirical antibiotic treatment

研究概览

简要总结

Spontaneous bacterial peritonitis (SBP) is a common complication of end-stage liver disease due to various causes. The initial anti-infective medication is appropriate and the patient's survival rate is closely related. Ascitic fluid bacterial culture takes a long time, the positive rate is low, it is difficult to guide the timely use of antimicrobial drugs, empirical medicine based on evidence-based medicine for SBP in patients with end-stage liver disease is essential. The American College of Hepatology and the European Society of Hepatology recommend the use of third-generation cephalosporins as the first choice of empirical therapy in patients with end-stage liver disease associated with community-acquired SBP. Patients with merger of hospital-acquired SBP with piperacillin / tazobactam or carbapenem +/- glycopeptide antibiotics is the first choice for empirical medication. There is no clear recommendation in China. In recent years, the conclusions of international clinical research in this area have been in disagreement with the recommendations. As a key factor in the selection of empirical antibiotics is local bacterial resistance data, these findings are difficult to evidence-based medicine for Chinese doctors. This project intends to observe the efficacy of different initial anti-infective regimens in Chinese patients with end-stage liver disease with SBP and 30-day and 60-day non-liver transplant survival rates, providing evidence-based medical evidence for the empirical use of such patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Meet the end-stage liver disease part of the type of standard (including slow plus acute liver failure, chronic liver failure, cirrhosis decompensation);
  • age> 18 years old
  • ascites nucleated cell count> 250 × 106 / L;
  • Unable to obtain ascites specimens or ascites nucleated cells count does not meet the conditions of 3) are required abdominal examination tenderness (+), rebound tenderness (+), abdominal ultrasound can detect ascites, and procalcitonin (PCT) > 0.5ng / ml, hs-CRP> 10ng / ml

排除标准

  • history of abdominal surgery within 4 weeks;
  • secondary peritonitis;
  • tuberculous peritonitis;
  • Malignant tumor;
  • patients who use hormones or immunosuppressants;
  • AIDS patients;
  • heart failure or respiratory failure;
  • merge other parts of the infection;
  • died within 48h;
  • liver transplantation during observation;
  • Diagnosis of spontaneous bacterial peritonitis is the use of carbapenems or third-generation cephalosporins / enzyme inhibitors, piperacillin / enzyme inhibitor antibiotics

研究组 & 干预措施

Infection Group

Patients with end stage liver disease with SBP

干预措施: Antibiotics (Drug)

结局指标

主要结局

Complete response rate to empirical antibiotic treatment

时间窗: 6 months

The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment

次要结局

  • Non-liver transplant survival(6 months)
  • Hospitalization time(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qin Ning

Director of Department of Infectious Disease

Tongji Hospital

研究点 (1)

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