Clinical Trials Directory

Trials / Completed

CompletedNCT07247539

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"

Diyalizat Saf Su Dijital Takip Sistemi

Status
Completed
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
Usak State Hospital · Academic / Other
Sex
All
Age
Healthy volunteers

Summary

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.

Detailed description

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.

Conditions

Interventions

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

Timeline

Start date
2025-07-15
Primary completion
2025-10-15
Completion
2025-11-01
First posted
2025-11-25
Last updated
2025-11-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07247539. Inclusion in this directory is not an endorsement.