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临床试验/NCT07247539
NCT07247539已完成不适用

Diyalizat Saf Su Dijital Takip Sistemi

Usak State Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Incidence of water quality parameters (pH, Chlorine, Conductivity) exceeding safe Hemodialysis guidelines limits as detected by the Pure Water Eye's instantaneous monitoring system, demonstrating the failure rate missed by standard periodic testing.

研究概览

简要总结

This study validates a novel, continuous, and instantaneous water quality monitoring method, the "Pure Water Eye," for hemodialysis (HD) systems. Current periodic testing leaves patients vulnerable to acute, severe complications like hemolysis due to sudden, undetectable failures in water quality (e.g., chlorine spikes, pH changes). The "Pure Water Eye" system continuously monitors five key parameters to establish an early warning mechanism, significantly increasing patient safety and allowing for the safe optimization of Reverse Osmosis (RO) water usage, thereby reducing water waste. This system is the first of its kind in Turkey, and globally, it addresses a critical gap where instantaneous and continuous monitoring of HD water quality is not standard practice.

详细描述

The safety of hemodialysis is critically dependent on the quality of the water used, as large volumes directly contact the patient's blood. The current standard of relying on periodic measurements (daily or weekly) fails to detect instantaneous fluctuations in contaminants (e.g., pH, conductivity, chlorine), which can lead to catastrophic events like hemolysis. The "Pure Water Eye" system was developed to perform four measurements per minute across five key parameters: pH, conductivity, chlorine, turbidity, and TDS. This prospective observational study investigated three scenarios: 1) Standard RO measurement, 2) RO waste water reduced by 50%, and 3) RO waste water directly routed back to the raw water tank. The study successfully demonstrated that continuous monitoring is vital for detecting sudden risk moments and is the only safe method for optimizing RO waste reduction without compromising water safety.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Hemodialysis Centre -

排除标准

  • 未提供

结局指标

主要结局

Incidence of water quality parameters (pH, Chlorine, Conductivity) exceeding safe Hemodialysis guidelines limits as detected by the Pure Water Eye's instantaneous monitoring system, demonstrating the failure rate missed by standard periodic testing.

时间窗: through study completion, an average of 3 months

Comparison of water conservation efficiency (reduction in RO waste water volume) between standard RO procedures and the optimized RO waste reduction scenario (Scenario 2: 50% waste reduction) safely managed by instantaneous monitoring.

时间窗: through study completion, an average of 3 months

次要结局

  • Validation of the correlation between instantaneous conductivity measurements and TDS (Total Dissolved Solids) readings to confirm the accuracy of the new method's core functionality.(through study completion, an average of 3 months)

研究者

发起方
Usak State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ender Hur

Professor

Usak State Hospital

研究点 (1)

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