NCT00875069已完成3 期
Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 1,460 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,460
- 试验地点
- 2
- 主要终点
- The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay
研究概览
简要总结
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.
详细描述
The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Patients of both genders, over 18 years,
- •Patients admitted in ICU
- •Dialysis catheter insertion for renal replacement therapy
- •At least two renal replacement therapy sessions
- •Written informed consent
- •Social security
排除标准
- •Pregnant or breastfeeding women
- •Patient requiring dialysis on arteriovenous fistula or permanent catheter
- •Known allergy to ethanol
- •Dialysis catheter covered or impregnated with antimicrobial agent
- •Dialysis catheter insertion before ICU admission
- •Single-lumen dialysis catheters
- •Patient whose death is likely to occur within hours after admission to ICU
研究组 & 干预措施
ethanol
Experimental
干预措施: Ethanol (Other)
placebo
Placebo Comparator
干预措施: Ethanol (Other)
结局指标
主要结局
The number of major catheter-related infections (CRI) defined as either catheter-related clinical sepsis without bloodstream infection or catheter-related bloodstream infection (CRBSI), during the ICU stay
时间窗: after renal replacement therapy session
次要结局
- frequencies of catheter colonization, severe mechanical complications, and adverse events(for two minutes before being withdrawn)
研究者
研究点 (2)
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