NCT00563342终止2 期
Catheters Dysfunction Rate After Instillation of Ethanol 60% Lock Solution in Tunneled Silicone Catheter of Chronic Hemodialysis Patients
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The catheters dysfunction rate
研究概览
简要总结
The primary objective of the study is to examine the risk of catheter dysfunction during the dialysis session that follows the instillation of ethanol 60% as lock solution in tunneled silicone catheters of end stage renal failure patients treated by hemodialysis.
The catheters dysfunction rate is the primary outcome. The dysfunction is defined as partial or complete occlusion or infection associated with dialysis catheter.
As a secondary outcome, the dialysis quality is also examined (urea reduction rate, total ultrafiltration)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
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,
- •Chronic hemodialysis 3 times a week, with two tunnel silicone catheters since at least 15 days,
- •Written informed consent
- •Social security
排除标准
- •Antibiotic therapy during selection phase,
- •Partial or complete catheter occlusion during selection phase,
- •Venous pressure at dialysis connection > 300 mmHg,
- •Known allergy to ethanol,
- •Patient involved in any other clinical trial or in the exclusion period
- •Severe co-morbidity
- •Acute or chronic infectious disease
- •Evolutive neoplasia,
- •HIV, HCV positive serology at inclusion,
- •Scheduled surgery
结局指标
主要结局
The catheters dysfunction rate
时间窗: as partial or complete occlusion or infection associated with dialysis catheter
次要结局
- The dialysis quality is also examined (urea reduction rate, total ultrafiltration)(as partial or complete occlusion or infection associated with dialysis catheter)
研究者
研究点 (2)
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