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OpenTrials
Completed

NCT Number: NCT07247539

Preventing Hemolysis and Reducing Reverse Osmosis Waste With Instantaneous Measurement of Water Quality and Early Warning System in Hemodialysis: A New Method, "Pure Water Eye"

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.

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Key information

Conditions

Water Quality Hemodialysis Complication Infections Water Consumption Water-Related Diseases Waterborne Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Usak Education and Research Hospital

Uşak, Merkez, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hemodialysis Centre -

Exclusion criteria

None

-

Treatment and study plan

Pure Water Eye Continuous Monitoring System

Diagnostic Test

Pure Water Eye Continuous Monitoring System (Continuous measurement of pH, conductivity, chlorine, turbidity, and TDS)

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 3 months

  2. 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.

    Time frame: through study completion, an average of 3 months

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 3 months

Sponsors and collaborators

Lead sponsor

Usak State Hospital

Other

Registry information

Official study title

Diyalizat Saf Su Dijital Takip Sistemi

Acronym: HEMOWAQNEWS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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