Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
研究概览
简要总结
This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.
详细描述
The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis.
Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prevalent PD patients with age >= 18 years old suffering from PD peritonitis
- •PD effluent white cell count >1090/mm2 on peritonitis day 3
- •Lack of clinical response
- •Informed consent available
排除标准
- •PD peritonitis in association with exit site or tunnel infection
- •Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy)
- •Fungal peritonitis
- •Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species)
- •Clinical suspicion of surgical peritonitis
- •Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used
研究组 & 干预措施
Lavage arm
Intravenous vancomycin & gentamicin with adjunctive lavage
干预措施: Intravenous vancomycin & gentamicin with adjunctive lavage (Drug)
Standard treatment arm
Intraperitoneal vancomycin & gentamicin
干预措施: Intraperitoneal vancomycin & gentamicin (Drug)
结局指标
主要结局
Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
时间窗: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
Number of participants requiring Tenckhoff catheter removal
时间窗: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment
次要结局
- Number of participants developing relapsing peritonitis(All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment)
- Number of participants requiring hospitalization(All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment)
研究者
Steve Siu-Man Wong
Associate Consultant
Alice Ho Miu Ling Nethersole Hospital