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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.

effect on the solute clearance in hemodialysis patients due to the use of dialyzers with different membrane properties and a novel device employing ultrasound

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/08/044562
Enrollment
160
Registered
2022-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

None listed

Sponsors

Sedign Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Patients not willing to participate, severe ischemia cardiac disease with poor left ventricular reserves will be excluded.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr Girish Namagondlu Seetharamaiah

KMYF Ranka Dialysis Centre

girishnamagondlu@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026