NCT04680039已完成不适用
Noninvasive Hemodynamic Parameters Measurements as a Tool for Early Warning of Intradialytic Hypotension in Hemodialysis Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of participants with intradialytic hypotension
研究概览
简要总结
In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with EKSD undergoing chronic hemodialysis treatments for > 3 months.
- •Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •Patients must satisfy a medical examiner about their fitness to participate in the study.
- •Patients must provide written informed consent to participate in the study.
排除标准
- •Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function).
- •Withholding the dialysis session for any reason prior to initiation.
- •Minors under the age of 18.
结局指标
主要结局
Number of participants with intradialytic hypotension
时间窗: Through study completion, an average of 1 year.
Using a PPG-based non-invasive wearable monitor to allow early detection of intradialytic hypotension
次要结局
- Determining the pathogenesis of intradialytic hypotension(Through study completion, an average of 1 year.)
研究者
研究点 (1)
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