Efficacy of Newer Polyethersulfone Dialyzers in Comparison to Standard Dialyzers
- Conditions
- End stage renal disease,
- Registration Number
- CTRI/2021/01/030330
- Lead Sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
- Brief Summary
Hemodialysis is an established therapy for both acute and end stage renal disease. Central to hemodialysis therapy is a biocompatible hollow dialyzer membrane for diffusive and convective transport of uremic toxins. New production technology has led to refinement in dialysis membrane leading to crucial enhancements of membrane porosity, reducing flow resistance and improving transport across the membrane. In the newer membrane structure of polyethersulfone dialyzers, fiber support region underneath the inner surface has been “opened upâ€, optimizing porosity and therefore also the convective filtration (“flushingâ€) of larger uremic toxins such as b2-microglobulin or myoglobin. At the same time the size of the pores of the inner surface area was not increased to avoid flushing of albumin. In an hemodialysis treatment, reducing the inner fiber diameter from 200 micro m to 185 micro m acts to increase internal filtration, this results in a greater pressure difference between the blood and dialysate compartments. Thus, improved fiber design allows for high selective permeability for middle molecules i.e. better sieving of middle molecules such as b2-microglobulin while restricting the loss of vital molecule albumin. In addition, increased clearance of pro-inflammatory molecules in a broad molecular weight range may attenuate the chronic inflammatory state in patients on dialysis. As increased levels of β2-m and loss of albumin are associated with higher mortality risk, the use of these newer dialyzers may be associated with better clinical outcomes.Objective of the study is to assess the clinical and biochemical performance of the modified polyethersulfone dialyzer compared to standard dialyzers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 45
Patients who are on a regular thrice-weekly HD schedule Patients who have good vascular access (fistula or graft) i.e. effective blood flow (> 300 ml/min) Patients who achieved a dialysis dose (Kt/V) of 1.2 to 1.4 in at least 4 sessions in last 1 month Patients who are on a stable anticoagulation, anemia and CKD-MBD management Patients who can understand the nature and requirements of the clinical investigation and have given written informed consent.
Patients who do not meet the inclusion criteria Patients with active HBV, HCV, HIV infection Patients who are severely malnourished patients (i.e. hypoalbuminemia defined as serum albumin concentration below 3.5 g/dL) Patients who have an active infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Removal rate and clearance of endogenous markers e.g. Urea, Creatinine, phosphate, b2- microglobulin and albumin. 0,3,6,9 months
- Secondary Outcome Measures
Name Time Method Inter and intra-dialytic blood pressure control Erythropoietin Responsiveness factor or EPO index (average weekly EPO dose in IU per kg BW in the preceding 4 weeks divided by the last measured hemoglobin)
Trial Locations
- Locations (1)
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences🇮🇳Lucknow, UTTAR PRADESH, IndiaManas R PatelPrincipal investigator9918810550drmrpatel@ymail.com