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Automated Setting of Individualized Sodium Technology (ASIST)

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
Artis Haemodialysis Machine w/ ASIST Software - Isotonic
Artis Haemodialysis Machine w/o ASIST Software
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD) focused on measuring Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), Chronic Hemodialysis, In-center HD, Sodium, Isotonic Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skane University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ASIST A

ASIST B

Conventional HD

Arm Description

Artis Haemodialysis Machine w/ ASIST Software - Isonatremic

Artis Haemodialysis Machine w/ ASIST Software - Isotonic

Artis Haemodialysis Machine w/o ASIST Software

Outcomes

Primary Outcome Measures

Evaluation of Blood Pressure
Evaluation of Heart Rate
Occurrence of Hypotensive Episodes
Change in Plasma Sodium
Change in Plasma Tonicity
Change in MCV (Erythrocyte Mean Corpuscular Volume)

Secondary Outcome Measures

Full Information

First Posted
May 17, 2016
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02795286
Brief Title
Automated Setting of Individualized Sodium Technology
Acronym
ASIST
Official Title
Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
Chronic Kidney Disease (CKD), End Stage Renal Disease (ESRD), Chronic Hemodialysis, In-center HD, Sodium, Isotonic Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASIST A
Arm Type
Experimental
Arm Description
Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
Arm Title
ASIST B
Arm Type
Experimental
Arm Description
Artis Haemodialysis Machine w/ ASIST Software - Isotonic
Arm Title
Conventional HD
Arm Type
Active Comparator
Arm Description
Artis Haemodialysis Machine w/o ASIST Software
Intervention Type
Device
Intervention Name(s)
Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
Intervention Type
Device
Intervention Name(s)
Artis Haemodialysis Machine w/ ASIST Software - Isotonic
Intervention Type
Device
Intervention Name(s)
Artis Haemodialysis Machine w/o ASIST Software
Primary Outcome Measure Information:
Title
Evaluation of Blood Pressure
Time Frame
Up to 9 weeks
Title
Evaluation of Heart Rate
Time Frame
Up to 9 weeks
Title
Occurrence of Hypotensive Episodes
Time Frame
Up to 9 weeks
Title
Change in Plasma Sodium
Time Frame
Up to 9 weeks
Title
Change in Plasma Tonicity
Time Frame
Up to 9 weeks
Title
Change in MCV (Erythrocyte Mean Corpuscular Volume)
Time Frame
Up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qing Li, MD
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Skane University Hospital
City
Malmö
State/Province
Skane
ZIP/Postal Code
205 02
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Automated Setting of Individualized Sodium Technology

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