Automated Setting of Individualized Sodium Technology

Not Applicable

Completed

• Conditions: End Stage Renal Disease (ESRD)
• Interventions: Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic; Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic; Device: Artis Haemodialysis Machine w/o ASIST Software

• Registration Number: NCT02795286
• Lead Sponsor: Vantive Health LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASIST A	Artis Haemodialysis Machine w/ ASIST Software - Isonatremic	Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
ASIST B	Artis Haemodialysis Machine w/ ASIST Software - Isotonic	Artis Haemodialysis Machine w/ ASIST Software - Isotonic
Conventional HD	Artis Haemodialysis Machine w/o ASIST Software	Artis Haemodialysis Machine w/o ASIST Software

Primary Outcome Measures

Name	Time	Method
Change in Plasma Sodium	Up to 9 weeks
Evaluation of Blood Pressure	Up to 9 weeks
Change in MCV (Erythrocyte Mean Corpuscular Volume)	Up to 9 weeks
Occurrence of Hypotensive Episodes	Up to 9 weeks
Change in Plasma Tonicity	Up to 9 weeks
Evaluation of Heart Rate	Up to 9 weeks

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Malmö, Skane, Sweden