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" (HEMOWAQNEWS)

November 21, 2025 updated by: Ender Hur, Usak State Hospital

Diyalizat Saf Su Dijital Takip Sistemi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Uşak, Merkez, Turkey (Türkiye)
        • Uşak Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Usak Education and Research Hospital Hemodialysis Centre

Description

Inclusion Criteria: Hemodialysis Centre -

Exclusion Criteria:None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: through study completion, an average of 3 months
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Usak State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 699-699-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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