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Completed

NCT Number: NCT02795286

Automated Setting of Individualized Sodium Technology

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.

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Key information

Conditions

End Stage Renal Disease (ESRD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skane University Hospital

Malmö, Skåne County, 205 02, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artis Haemodialysis Machine w/ ASIST Software - Isonatremic

Device

Artis Haemodialysis Machine w/ ASIST Software - Isotonic

Device

Artis Haemodialysis Machine w/o ASIST Software

Device

Primary outcomes

  1. Evaluation of Blood Pressure

    Time frame: Up to 9 weeks

  2. Evaluation of Heart Rate

    Time frame: Up to 9 weeks

  3. Occurrence of Hypotensive Episodes

    Time frame: Up to 9 weeks

  4. Change in Plasma Sodium

    Time frame: Up to 9 weeks

  5. Change in Plasma Tonicity

    Time frame: Up to 9 weeks

  6. Change in MCV (Erythrocyte Mean Corpuscular Volume)

    Time frame: Up to 9 weeks

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

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

Acronym: ASIST

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2016
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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