Status:
NOT_YET_RECRUITING
Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
End Stage Renal Disease
Chronic Hemolysis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins (such as p-cresyl sulfate (p-CS) or indoxyl sulfate (IS)) due to their strong binding to serum albumin. The accum...
Eligibility Criteria
Inclusion
- Age ≥18 years
- On haemodialysis at a frequency of 3 sessions of 4 hours per week, for at least 3 months.
- For patients of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) for the entire duration of treatment is required. A blood pregnancy test (beta-human chorionic gonadotropin (HCG)) will be carried out at inclusion.
- Patient affiliated to a social security scheme
- Free, informed and written consent signed by the patient
Exclusion
- Residual diuresis \> 100 mL per day
- Pregnant or breast-feeding
- Uncontrolled hypertension \> 180/115 millimetre of mercury (mmHg)
- Perdialytic hypotension requiring vascular filling \> 100 mL during the last 3 sessions
- Patients already on parenteral nutrition
- Patients already on Vitamin K antagonists (VKA) (or prescribed less than one month before inclusion)
- Patients with allergy to heparin or requiring haemodialysis without anticoagulant (recent haemorrhage)
- Criteria relating to products/procedures: Patient with
- an allergy to egg, soya or peanut proteins or to one of the active ingredients or one of the excipients (glycerol, egg phospholipids for injection, a-tocopherol, sodium oleate (to adjust the pH), water for injection) of Médialipide
- Severe hyperlipidaemia or severe lipid metabolism disorder characterised by hypertriglyceridaemia \> 3 mmol/l
- Sepsis \< 1 month
- Severe liver failure or cholestasis
- Known severe coagulopathy
- Acute thrombo-embolic events
- Fat embolism
- Aggravating bleeding diathesis,
- Uncompensated metabolic acidosis.
- Unstable circulatory state threatening the vital prognosis (collapse and shock),
- Unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin),
- Acute phase of myocardial infarction or stroke,
- Uncorrected disturbances of fluid and electrolyte balance, such as hypokalaemia and hypotonic dehydration.
- Decompensated heart failure,
- Acute pulmonary oedema.
- Subject participating in another interventional study involving a drug with an exclusion period still in progress at inclusion.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 22 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06595680
Start Date
January 1 2025
End Date
January 22 2027
Last Update
September 19 2024
Active Locations (1)
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1
Hopital Edouard Herriot
Lyon, France, 69003