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"

NCT ID: NCT07247539

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-11-01

Brief 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

Water Quality; Water Consumption; Water-Related Diseases; Hemodialysis Complication

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Pure Water Eye Continuous Monitoring System

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Usak State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ender Hur

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Usak Education and Research Hospital

Uşak, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

de Oliveira RM, de los Santos CA, Antonello I, d'Avila D. Warning: an anemia outbreak due to chloramine exposure in a clean hemodialysis unit--an issue to be revisited. Ren Fail. 2009;31(1):81-3. doi: 10.1080/08860220802546503.

Reference Type: RESULT

PMID: 19142815 (View on PubMed)

Kasparek T, Rodriguez OE. What Medical Directors Need to Know about Dialysis Facility Water Management. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1061-71. doi: 10.2215/CJN.11851214. Epub 2015 May 15.

Reference Type: RESULT

PMID: 25979976 (View on PubMed)

Barraclough KA, Moller S, Blair S, Knight R, Agar JW, McAlister S, White A, Sypek M. Updating the Data: The Resource Consumption of Modern-Day Hemodialysis Systems. Kidney Int Rep. 2024 Feb 12;9(5):1521-1524. doi: 10.1016/j.ekir.2024.02.010. eCollection 2024 May. No abstract available.

Reference Type: RESULT

PMID: 38707837 (View on PubMed)

Other Identifiers

699-699-03

Identifier Type: -

Identifier Source: org_study_id