Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 主要终点
- all cause mortality
研究概览
简要总结
This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.
详细描述
Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥16 years
- •the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours
- •ICU stay of at least 5 days
- •APACHE Ⅱ score within 24 hours of randomization of 16 or more
- •severe sepsis
- •written informed consent -
排除标准
- •documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study;
- •fluconazole/caspofungin allergy;
- •pregnant of lactating woman;
- •life expectancy of 48 hours or less. -
研究组 & 干预措施
Prophylactic group
Patients would received intravenous fluconazole (loading dose 800 mg, then 400 mg/day) or caspofungin (loading dose 70 mg, then 50 mg/day) if patients had organ failure or renal or liver dysfunction during the immediately surgery. The antifungal treatment would continue for 5 to 7 days.
干预措施: fluconazole and caspofungin (Drug)
结局指标
主要结局
all cause mortality
时间窗: six months
次要结局
- fungal infection(six months)
研究者
Gao Tao
Clinical Professor
Nanjing PLA General Hospital