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"

NCT07247539 | Completed

• 1 other identifier: 699-699-03
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  through study completion, an average of 3 months

Interventions

Pure Water Eye Continuous Monitoring System DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Usak Education and Research Hospital Hemodialysis Centre

Sponsors & Collaborators

• Usak State Hospital: lead

Study Sites (1)

Usak Education and Research Hospital

Uşak, Merkez, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 19142815 RESULT

• 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.

  PMID: 25979976 RESULT

• 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.

  PMID: 38707837 RESULT

MeSH Terms

Conditions

Waterborne Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 25, 2025
• Study Start: July 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)