triglycerides, medium chain; soya oil for End-stage kidney disease on chronic hemodialysis (chronic hemodialysis-dependent kidney failure)

Inclusion criteria

• {"criterion_text":"- Age ≥18 years"}
• {"criterion_text":"- On hemodialysis at a frequency of 3 4-hour sessions per week (+/- 30 minutes), for at least 1 month"}
• {"criterion_text":"- For patients of childbearing potential, highly effective contraception (e.g. total sexual abstinence, combined hormonal contraception, bilateral tubal obstruction, etc.) is required for the entire duration of treatment. A blood pregnancy test (beta-HCG) will be performed at inclusion."}
• {"criterion_text":"- Patient affiliated to a social security scheme"}
• {"criterion_text":"- Free, informed and written consent signed by the patient"}

Exclusion criteria

• {"criterion_text":"- Residual diuresis > 100 mL per day"}
• {"criterion_text":"- Patients with sepsis < 1 month"}
• {"criterion_text":"- Patient with severe liver failure or cholestasis"}
• {"criterion_text":"- Patient with known severe coagulopathy"}
• {"criterion_text":"- Patient with acute thromboembolic events"}
• {"criterion_text":"- Patient with fat embolism"}
• {"criterion_text":"- Patient with an aggravating bleeding diathesis"}
• {"criterion_text":"- Patient with uncompensated metabolic acidosis"}
• {"criterion_text":"- Patient with an unstable circulatory state threatening the vital prognosis (collapse and shock)"}
• {"criterion_text":"- Patients with unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin)"}
• {"criterion_text":"- Patients in the acute phase of myocardial infarction or stroke"}
• {"criterion_text":"- Pregnant or breastfeeding"}
• {"criterion_text":"- Subject having participated in another interventional research study in the 30 days prior to inclusion in the study or still within 5 half-lives of the experimental product of a previous interventional research study."}
• {"criterion_text":"- Uncontrolled hypertension > 180/115 mmHg"}
• {"criterion_text":"- Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions"}
• {"criterion_text":"- Patient already on parenteral nutrition"}
• {"criterion_text":"- Patient already on antivitamin K (or prescribed less than one month prior to inclusion)"}
• {"criterion_text":"- Patient with heparin allergy or requiring hemodialysis without anticoagulant (recent hemorrhage)"}
• {"criterion_text":"- Patients allergic to egg, soy or peanut proteins or to any of the active ingredients or excipients (glycerol, egg phospholipids for injection, a-tocopherol, sodium oleate (for pH adjustment), water for injection) of Médialipide®"}
• {"criterion_text":"- Patients with severe hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia > 3 mmol/l"}
• {"criterion_text":"- Patients on non-steroidal anti-inflammatory drugs"}
• {"criterion_text":"- Patients under legal protection"}
• {"criterion_text":"- Persons incapable of expressing their consent"}
• {"criterion_text":"- Persons deprived of their liberty and emergency situations."}

Primary endpoints

• {"endpoint_text":"- 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 total concentration in dialysate, C arterial uremic toxin total concentration in blood taken from the arterial port of the dialyzer.","definition_or_measurement_approach":"Dialysis clearance defined by formula: Clearance = Qd × (C dialysate / C arterial); calculated over 240 minutes with Qd = dialysate flow rate, C_dialysate = total uremic toxin concentration in dialysate, C_arterial = total uremic toxin concentration in arterial blood from the dialyzer."}

Secondary endpoints

• {"endpoint_text":"- The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Total concentration (t=0 min) - Total concentration (t=240 min ))/Total concentration (t= 0 min) (arterial C)","definition_or_measurement_approach":"Reduction fraction RF (%) = (Total concentration at t=0 - Total concentration at t=240) / Total concentration at t=0 (arterial concentration)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clearance and reduction fraction calculated over 240 minutes for listed protein-bound uremic toxins (measured arterial concentrations and dialysate concentrations as applicable)."}
• {"endpoint_text":"- Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session.","definition_or_measurement_approach":"Proportion of patients experiencing ≥1 of specified adverse events (nausea, vomiting, headache) during the hemodialysis session."}
• {"endpoint_text":"- 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, total bilirubin) or significant hemolysis during follow-up.","definition_or_measurement_approach":"Proportion of patients meeting any listed laboratory safety criteria (triglycerides threshold, liver enzyme/bilirubin abnormalities) or significant hemolysis during follow-up."}
• {"endpoint_text":"- Kinetics of plasma concentrations of medium‑chain fatty acids (octanoate and decanoate) during the hemodialysis session (T0, T60, T120, T180, T240).","definition_or_measurement_approach":"Serial plasma measurements of octanoate and decanoate at T0, T60, T120, T180, T240 to describe concentration-time kinetics."}
• {"endpoint_text":"- Free and total concentrations of uremic toxins throughout the hemodialysis session (T0, T15, T30, T45, T60, T90, T120, T180, T240) (arterial concentration).","definition_or_measurement_approach":"Serial arterial measurements of free and total concentrations of uremic toxins at specified timepoints throughout session."}
• {"endpoint_text":"- Total amount of uremic toxins eliminated at the end of the hemodialysis session: mass transfer calculation Tm = R × C_sample × V_sample (R = ratio between the total dialysate flow and the sampled flow, C_sample = concentration sampled at T240, and V_sample = sampled volume). Sample flow rate = total dialysate volume / sampling duration.","definition_or_measurement_approach":"Mass transfer calculation using sampled dialysate concentration at T240, sampled volume and ratio R (total dialysate flow / sampled flow); sample flow rate derived from total dialysate volume and sampling duration."}
• {"endpoint_text":"- Clearance of medium‑chain fatty acids (octanoate and decanoate) during the hemodialysis session (T0, T60, T120, T180, T240).","definition_or_measurement_approach":"Clearance calculations for octanoate and decanoate over listed timepoints, analogous to dialysis clearance formula using dialysate and arterial concentrations."}

France

Latest Decision Or Authorization Date

04-06-2025

Number Of Sites

1

Number Of Participants

12

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France