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Clinical Trial Details

Trial ID: L0713
Source ID: NCT06595680
Associated Drug: Medialipide 20% Perfusion
Title: Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
Acronym: CLEARTOX
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease|Chronic Hemolysis
Interventions: DRUG: Medialipide 20% perfusion|DRUG: NaCl 0,9%|BIOLOGICAL: Blood sample
Outcome Measures: Primary: Dialytic clearance of p-CS, Dialysis clearance of p-CS (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-CS in the dialysate, C arterial the concentration of p-CS in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session | Secondary: Reduction fraction (RF) of p-CS, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of p-CS at T0 - Concentration of p-CS at T240)/Concentration of p-CS at T0, At 240 minutes after haemodialysis session|Dialytic clearance of Indoxyl sulfate, Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of Indoxyl sulfate in the dialysate, C arterial the concentration of Indoxyl sulfate in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of Indoxyl sulfate, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of Indoxyl sulfate at T0 - Concentration of Indoxyl sulfate at T240)/Concentration of Indoxyl sulfate at T0, At 240 minutes after haemodialysis session|Dialytic clearance of hippuric acid, Dialysis clearance of hippuric acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of hippuric acid in the dialysate, C arterial the concentration of hippuric acid in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of hippuric acid, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of hippuric acid at T0 - Concentration of hippuric acid at T240)/Concentration of hippuric acid at T0, At 240 minutes after haemodialysis session|Dialytic clearance of p-cresyl glucuronide, Dialysis clearance of p-cresyl glucuronide (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of p-cresyl glucuronide in the dialysate, C arterial the concentration of p-cresyl glucuronide in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of p-cresyl glucuronide, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of p-cresyl glucuronide at T0 - Concentration of p-cresyl glucuronide at T240)/Concentration of p-cresyl glucuronide at T0, At 240 minutes after haemodialysis session|Dialytic clearance of indol acetic acid, Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of indol acetic acid in the dialysate, C arterial the concentration of indol acetic acid in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of indol acetic acid, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of indol acetic acid at T0 - Concentration of indol acetic acid at T240)/Concentration of indol acetic acid at T0, At 240 minutes after haemodialysis session|Dialytic clearance of uric acid, Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of uric acid in the dialysate, C arterial the concentration of uric acid in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of uric acid, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of uric acid at T0 - Concentration of uric acid at T240)/Concentration of uric acid at T0, At 240 minutes after haemodialysis session|Dialytic clearance of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid, Dialysis clearance of indol acetic acid (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the dialysate, C arterial the concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|Reduction fraction (RF) of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid, Reduction fraction will be measured in percentage Reduction fraction will be compared between the medialipide perfusion situation and the NACL 0,9% perfusion situation. RF (%) = (Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0 - Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T240)/Concentration of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid at T0, At 240 minutes after haemodialysis session|Tolerance of medialipide perfusion (%), Percentage of patients with the occurrence of at least one symptom including: nausea, emesis, headaches during the hemodialysis session, until 240 minutes after haemodialysis session|Safety of medialipide perfusion, % of patients who presented one of the following event : hypertriglyceridemia \> 4 gram/liter, alteration of liver test (cytolysis \> 2 times the normal value, cholestasis \> 2 times the normal value), or hemolysis., until 7 days after the last haemodialysis session|octanoate blood concentration, until 240 minutes after haemodialysis session|decanoate blood concentration, until 240 minutes after haemodialysis session|clearance of octanoate, Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of octanoate in the dialysate, C arterial the concentration of octanoate in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session|clearance of decanoate, Dialysis clearance of Indoxyl sulfate (millilitre/minute) is defined as follows: Clearance = Qd X (C dialysate/C arterial) with Qd corresponding to the dialysate flow rate, C dialysate the concentration of decanoate in the dialysate, C arterial the concentration of decanoate in the blood sampled at the arterial port of the dialyser., until 240 minutes after haemodialysis session
Sponsor/Collaborators: Sponsor: Hospices Civils de Lyon
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-01
Completion Date: 2027-01-22
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Hopital Edouard Herriot, Lyon, 69003, France
URL: https://clinicaltrials.gov/show/NCT06595680