This will be a prospective, nonrandomized, single-blind, crossover trial. The study will be performed in two different phases, with each subject used as his/her own control. Dry weight, dialysis prescription, and medications will not be modified during the entire study.
Not Applicable
- Conditions
- Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
- Registration Number
- CTRI/2022/08/044562
- Lead Sponsor
- Sedign Solutions Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All patients on HD for at least three months will be enrolled from our dialysis unit. Patients who are receiving thrice weekly or twice weekly HD with volumetric dialysis machines using bicarbonate-based dialysate and polysulfone dialyzer will be selected. Patients will be in stable clinical condition and stable prescribed dry weight.
Exclusion Criteria
Patients not willing to participate, severe ischemia cardiac disease with poor left ventricular reserves will be excluded.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study aims to address the issue of dialysis inadequacy (low Kt/V and URR) faced during maintenance hemodialysis. The use of dialyzers with different membrane properties and ultrasound is anticipated to promote diffusion and increase the solute clearance from the blood. It would help the dialysis patients achieve the prescribed Kt/V target and reduce the morbidity and mortality of end stage renal disease.Timepoint: Time taken for each subject (if it involves interviews, follow up period): 300 - 400 hours (up to 80 dialysis sessions)
- Secondary Outcome Measures
Name Time Method This will be a prospective, nonrandomized, single-blind, crossover trial. The study will be performed in two different phases, with each subject used as his/her own control. Dry weight, dialysis prescription, and medications will not be modified during the entire study. In the first phase, patients will undergo a fixed number of HD sessions (up to 36 sessions) with the treatment of one arm of the study. In the second phase, the same patients will be crossed-over to a treatment of another arm of the study for the same number of HD sessions.Timepoint: The sessions will be conducted using a standard dialysis prescription of blood flow �150 mL/min and dialysate flow � 300 mL/min. The standard dialysate composition will be as follows : bicarbonate 35 mEq/L, potassium 2.0 mEq/L, calcium 1.5 millimoles/L, magnesium 1.0 mEq/L, chloride 109.5 mEq/L. The prescribed dialysate sodium concentration will be fixed at 140 mEq/L, which is the standard concentration used at our dialysis facility.