Automated Setting of Individualized Sodium Technology

Study Overview
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Brief Summary
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The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.

Official Title
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Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study

Conditions
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End Stage Renal Disease (ESRD)

Intervention / Treatment
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* Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
* Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic
* Device: Artis Haemodialysis Machine w/o ASIST Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be in clinically stable condition as judged by the treating physician, and demonstrated by stable medical history, physical examination, and laboratory testing for 30 days prior to enrollment. Subject must be receiving HD or hemodiafiltration (HDF) for at least 30 days prior to study enrollment, be dialyzing a minimum of 3 times per week in an in-center setting and each treatment session must be between 3.5 and 5 hours in duration. Subject has a stable functioning vascular access (arteriovenous [AV] fistula, graft, or dual-lumen tunneled catheter) based on the judgment of the treating physician and is performing dual-needle therapy with an actual blood flow rate of 250 - 400 mL/min. Subject has a pre-dialysis plasma sodium of ≥132 mmol/L for at least 60 days prior to study enrollment. Subject has achieved a dialysis dose of stdKt/Vurea ≥ 2.1 within 60 days prior to enrollment. Subject has a pre-dialysis hemoglobin ≥ 90 g/L measured at Screening. Exclusion Criteria: Female subjects who are pregnant, lactating, or planning to become pregnant during the study period. Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide Informed Consent and/or comply with protocol procedures. Subjects with a medical condition that the investigator thinks may interfere with the study objectives. Subjects with significant signs of access recirculation as judged by the treating physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASIST A<br>Artis Haemodialysis Machine w/ ASIST Software - Isonatremic | Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic<br> <br> |
| Experimental: ASIST B<br>Artis Haemodialysis Machine w/ ASIST Software - Isotonic | Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic<br> <br> |
| Active Comparator: Conventional HD<br>Artis Haemodialysis Machine w/o ASIST Software | Device: Artis Haemodialysis Machine w/o ASIST Software<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Blood Pressure |  | Up to 9 weeks | 
| Evaluation of Heart Rate |  | Up to 9 weeks | 
| Occurrence of Hypotensive Episodes |  | Up to 9 weeks | 
| Change in Plasma Sodium |  | Up to 9 weeks | 
| Change in Plasma Tonicity |  | Up to 9 weeks | 
| Change in MCV (Erythrocyte Mean Corpuscular Volume) |  | Up to 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), Chronic Hemodialysis, In-center HD, Sodium, Isotonic Dialysis