jRCT1062230034已完成不适用
A single-center open-label crossover study of the clinical utility and safety of the BV-UFC system of the DCS-200Si dialysis monitor
未提供0 个研究点目标入组 20 人开始时间: 2023年6月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- The number of times of hypotension during dialysis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 90age old under（—）
- 性别
- All
入选标准
- •(1) Patients who give written consent to participate in this study of their own free will.
- •(2)Hemodialysis patients who are outpatients or inpatients undergoing hemodialysis (regardless of the underlying disease)
- •(3)Patients who are between 20 and 90 years old (regardless of gender) at the time of consent
- •(4)Patients who can be get a blood flow rate of 200 mL/min or more by vascular access
- •(5)Patients who have been receiving hemodialysis for at least 3 months at the time of participation in this study
排除标准
- •Of those who meet the above selection criteria, those who meet any of the following criteria shall not be eligible for enrollment.
- •(1) Patients participating in other clinical research or clinical trials
- •(2)Those who are pregnant
- •(3)Patients who have vascular access recirculation
- •(4) Patients who are deemed by the investigator to be inappropriate to participate in the study.
结局指标
主要结局
The number of times of hypotension during dialysis
Dialysis hypotension is defined as a sudden drop in blood pressure of 20 mmHg or more as systolic blood pressure or a symptomatic drop in mean blood pressure of 10 mmHg or more during dialysis. Basically, blood pressure should be measured every 20 minutes during hemodialysis. Even if blood pressure is measured multiple times within 20 minutes due to symptoms such as feeling unwell, only the lowest systolic blood pressure should be recorded as the valid count.
次要结局
- Average plasma refilling rate during dialysis(entire period of dialysis, 0-1 hour, 1-2 hours, and 2-3 hours after the start of dialysis)
- Blood pressure variation during dialysis
- Number of times systolic blood pressure decreased significantly
- Amount of vasopressors used during hemodialysis(per hemodialysis session)
- Percentage of patients achieving target ultrafiltration rate(at the end of hemodialysis)
- Number of dialysis monitoring device operations and procedures(per hemodialysis session)
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