chronic hemodialysis patients (for more than 3 months) with no residual diuresis (<100 mL/day).
Conditions
Brief summary
Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.
Detailed description
The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Concentration (t=0 min) - Concentration (t=240 min ))/Concentration (t= 0 min), Clearance and reduction fraction (over 240 minutes) of other protein-bound uremic toxins during the hemodialysis session: indoxyl sulfate, hippuric acid, p-cresyl glucuronide, 3-indole acetic acid, uric acid and 3-carboxy-4-methyl-5propyl-furanpro-pionic acid., Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session., Safety: % of patients with one of the following events: triglyceridemia > 4 g/L or 4.6 mmol/L at the end of the session, alteration in liver balance (ALT, ASAT, gamma GT, PAL, free and conjugated bilirubin) or significant hemolysis during follow-up., Comparison of plasma concentration of medium-chain fatty acids (octanoate and decanoate) between start and end of infusion.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer. | — |
Secondary
| Measure | Time frame |
|---|---|
| The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Concentration (t=0 min) - Concentration (t=240 min ))/Concentration (t= 0 min), Clearance and reduction fraction (over 240 minutes) of other protein-bound uremic toxins during the hemodialysis session: indoxyl sulfate, hippuric acid, p-cresyl glucuronide, 3-indole acetic acid, uric acid and 3-carboxy-4-methyl-5propyl-furanpro-pionic acid., Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session., Safety: % of patients with one of the following events: triglyceridemia > 4 g/L or 4.6 mmol/L at the end of the session, alteration in liver balance (ALT, ASAT, gamma GT, PAL, free and conjugated bilirubin) or significant hemolysis during follow-up., Comparison of plasma concentration of medium-chain fatty acids (octanoate and decanoate) between start and end of infusion. | — |
Countries
France