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Automated Setting of Individualized Sodium Technology (ASIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795286
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease (ESRD) Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic Device: Artis Haemodialysis Machine w/o ASIST Software Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
Study Start Date : March 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795286


Locations
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Sweden
Skane University Hospital
Malmö, Skane, Sweden, 205 02
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Qing Li, MD Baxter Healthcare Corporation
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02795286    
Other Study ID Numbers: 1407-005
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Baxter Healthcare Corporation:
Chronic Kidney Disease (CKD)
End Stage Renal Disease (ESRD)
Chronic Hemodialysis
In-center HD
Sodium
Isotonic Dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency