Automated Setting of Individualized Sodium Technology

End Stage Renal Disease (ESRD) Clinical Trial

— ASIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795286
• Other study ID #: 1407-005
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: April 19, 2017
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Artis Haemodialysis Machine w/ ASIST Software - Isonatremic

• Artis Haemodialysis Machine w/ ASIST Software - Isotonic

• Artis Haemodialysis Machine w/o ASIST Software

Locations

Country	Name	City	State
Sweden	Skane University Hospital	Malmö	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Blood Pressure		Up to 9 weeks
Primary	Evaluation of Heart Rate		Up to 9 weeks
Primary	Occurrence of Hypotensive Episodes		Up to 9 weeks
Primary	Change in Plasma Sodium		Up to 9 weeks
Primary	Change in Plasma Tonicity		Up to 9 weeks
Primary	Change in MCV (Erythrocyte Mean Corpuscular Volume)		Up to 9 weeks