The main goal of this clinical study is to evaluate the safety of the Qidni/D Hemodialysis System in patients with end-stage renal disease. The main question it aims to answer is: Is the Qidni/D safe for performing hemodialysis? Participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the Qidni/D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Qidni/D is a hemodialysis device for patients with end-stage renal disease.
Qidni Labs
Kitchener, Ontario, Canada
RECRUITINGIncidence and severity of adverse events associated with the use of the Qidni/D device
Adverse events will be recorded and adjudicated independently as to the severity and likelihood of association with treatment with the Qidni/D device.
Time frame: 3 days
Efficacy of dialysis
Evaluate the adequacy of dialysis achieved with the Qidni/D device by assessing the change of urea between start and end of dialysis, and compare it to subject's dialysis history.
Time frame: 1 day
Efficacy of dialysis
Evaluate the effectiveness of the Qidni/D device in terms of its ability to adequately remove waste products from the subject's blood. This is assessed by the incidence of serum potassium within target range (as established by laboratory normal values) at the end of dialysis treatment.
Time frame: 1 day
Efficacy of dialysis
Evaluate the adequacy of dialysis achieved with the Qidni/D device by assessing the change of serum creatinine between start and end of dialysis.
Time frame: 1 day
Efficacy of dialysis
Evaluate the adequacy of dialysis with respect to middle molecule clearance achieved with the Qidni/D device by assessing the change of serum beta-2 microglobulin between start and end of dialysis.
Time frame: 1 day
Efficacy of dialysis
Evaluate the ability of the Qidni/D device to accurately remove fluid from the subject during dialysis by comparing the device specified targeted fluid removal with the mass of the fluid removed in kilograms.
Time frame: 1 day
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Hemodynamic stability
Incidence of intradialytic hypotension measured by intradialytic blood pressure less than 90 mmHg systolic with associated symptoms (nausea, vomiting, sweating, dizziness, chest pain).
Time frame: 1 day
Technical performance of the Qidni/D device
Number of dialysis sessions interrupted or discontinued due to device malfunction.
Time frame: 1 day