Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins

Launched by HOSPICES CIVILS DE LYON · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new method of hemodialysis, a treatment for patients with end-stage kidney disease, to better remove harmful substances from the blood. These harmful substances, known as protein-bound uremic toxins, can build up in patients who are on hemodialysis and may lead to serious health issues. The study will test a special emulsion called Medialipide®, which contains medium-chain fatty acids that could help release these toxins from the proteins in the blood, making it easier for them to be removed during dialysis.

To be eligible for this trial, participants must be at least 18 years old and have been undergoing hemodialysis three times a week for at least three months. They should not have certain medical conditions, such as uncontrolled high blood pressure or severe allergies to specific ingredients in Medialipide®. If eligible, participants will receive either Medialipide® or a standard saline solution during their hemodialysis sessions. This study aims to see if using Medialipide® improves the removal of these toxins compared to standard care, which could potentially lead to better health outcomes for patients on hemodialysis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.