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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

Tracking Information
First Submitted Date  ICMJE May 17, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date April 20, 2017
Study Start Date  ICMJE March 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Evaluation of Blood Pressure [ Time Frame: Up to 9 weeks ]
  • Evaluation of Heart Rate [ Time Frame: Up to 9 weeks ]
  • Occurrence of Hypotensive Episodes [ Time Frame: Up to 9 weeks ]
  • Change in Plasma Sodium [ Time Frame: Up to 9 weeks ]
  • Change in Plasma Tonicity [ Time Frame: Up to 9 weeks ]
  • Change in MCV (Erythrocyte Mean Corpuscular Volume) [ Time Frame: Up to 9 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Setting of Individualized Sodium Technology
Official Title  ICMJE Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease (ESRD)
Intervention  ICMJE
  • Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
  • Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic
  • Device: Artis Haemodialysis Machine w/o ASIST Software
Study Arms  ICMJE
  • Experimental: ASIST A
    Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
    Intervention: Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic
  • Experimental: ASIST B
    Artis Haemodialysis Machine w/ ASIST Software - Isotonic
    Intervention: Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic
  • Active Comparator: Conventional HD
    Artis Haemodialysis Machine w/o ASIST Software
    Intervention: Device: Artis Haemodialysis Machine w/o ASIST Software
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795286
Other Study ID Numbers  ICMJE 1407-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qing Li, MD Baxter Healthcare Corporation
PRS Account Baxter Healthcare Corporation
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP