NCT02890875终止不适用
Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Central line-associated bloodstream infection
研究概览
简要总结
Patients on long-term parenteral nutrition (PN) are at high risk for central line-associated bloodstream infections (CLABSI). This study evaluates the efficacy and safety of ethanol lock therapy for CLABSI prophylaxis in adult patients on PN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (ages 18-80) on PN with silicone-based central venous catheters
排除标准
- •Weight ≤ 50 kg
- •Allergy/hypersensitivity/intolerance to ethanol or heparin
- •Pregnancy or breastfeeding
- •Patient taking metronidazole, disulfiram, or isoniazid
- •History of alcohol abuse
- •History of heparin-induced thrombocytopenia (HIT) or have an active hypocoagulable state
研究组 & 干预措施
Ethanol lock
Active Comparator
70% ethanol
干预措施: Ethanol lock (Other)
Heparin lock
Active Comparator
Heparinized saline (100 U/mL)
干预措施: Heparin lock (Other)
结局指标
主要结局
Central line-associated bloodstream infection
时间窗: 12 months
次要结局
- Catheter-related complication(12 months)
- New self-reported symptoms(12 months)
- Hospitalization(12 months)
- SIRS/sepsis(12 months)
研究者
Berkeley Limketkai
Clinical Assistant Professor
Stanford University
研究点 (2)
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