Automated Setting of Individualized Sodium Technology (ASIST)

March 11, 2025 updated by: Vantive Health LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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

  • Sweden
    • Skane
      • Malmö, Skane, Sweden, 205 02
        • Skåne University 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Vantive Health LLC

Collaborators

Baxter Healthcare Corporation

Investigators

  • Study Director: Qing Li, MD, Baxter Healthcare Corporation

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

March 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (Estimated)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1407-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on End Stage Renal Disease (ESRD)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe