Clinical trial NCT02795286: Automated Setting of Individualized Sodium Technology
Official title: Automated Setting of Individualized Sodium Technology (ASIST) - Proof of Principle Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Keywords: Chronic Kidney Disease (CKD)
End Stage Renal Disease (ESRD)
Chronic Hemodialysis
In-center HD
Sodium
Isotonic Dialysis
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2016-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluation of Blood Pressure
timeFrame: Up to 9 weeks
measure: Evaluation of Heart Rate
timeFrame: Up to 9 weeks
measure: Occurrence of Hypotensive Episodes
timeFrame: Up to 9 weeks
measure: Change in Plasma Sodium
timeFrame: Up to 9 weeks
measure: Change in Plasma Tonicity
timeFrame: Up to 9 weeks
measure: Change in MCV (Erythrocyte Mean Corpuscular Volume)
timeFrame: Up to 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital
state: Skane
Study officials:
References: