NCT05300191暂停不适用
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- CloudCath
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Conductivity measurements of effluent dialysate solutions.
研究概览
简要总结
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen.
- •Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient.
- •Specimens shall not contain any individually identifiable information from the patient it was obtained from.
排除标准
- •Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis.
- •Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer.
- •Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.
结局指标
主要结局
Conductivity measurements of effluent dialysate solutions.
时间窗: immediately post dialysis
a quantitative assessment of conductivity of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score.
Spectral measurements of effluent dialysate solutions
时间窗: immediately post dialysis
a quantitative analysis of the spectral characteristics of the effluent dialysate solution using a proprietary algorithm and sensing equipment that results in a quantitative CloudCath Score.
次要结局
未报告次要终点
研究者
研究点 (1)
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