Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: Dialysis with "high sieving" polyethersulfone dialyzers: Dialysis with "high sieving" polyethersulfone dialyzers
Control Intervention1: Dialysis with Standard Dialyzers: Dialysis with S
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow India
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Removal rate and clearance of endogenous markers e.g. Urea, Creatinine, phosphate, b2- microglobulin and albumin. Timepoint: 0,3,6,9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) Time-averaged serum albumin level Quality of life measures (SF-36/KDQOL-36 questionnaire) Adverse effects: AEs and SAEs using the Common Terminology Criteria for AEs (CTCAE v5.0)Timepoint: 0,3,6,9 months | — |
Countries
India
Contacts
Public ContactDr Manas Ranjan Patel
SGPGI
Outcome results
None listed