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Not yet recruiting NCT06595680

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

Phase II Interventional End Stage Renal Disease Chronic Hemolysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medialipide 20% perfusion, NaCl 0,9%, Blood sample.
Who it may be relevant to
Registry conditions: End Stage Renal Disease, Chronic Hemolysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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 accumulation of these toxins in end-stage renal failure patients on hemodialysis is strongly suspected to contribute to the significant morbidity and mortality observed in this population. Pre-clinical studies conducted previously showed that medium-chain fatty acids (such as sodium octanoate and decanoate), which are natural ligands of albumin, can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session. Medialipide® 20% (Braun) is an emulsion of medium chain triglycerides (MCT) (6 to 12 carbons) used in parenteral nutrition. Medialipide® constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94% of sodium octanoate and decanoate. In this study, a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide® emulsion (as a sodium octanoate and decanoate donor) in patients during their hemodialysis session compared to a control situation Sodium chloride (NaCl) 0,9%).

Interventions

  • Drug Medialipide 20% perfusion
    Each patient will receive during a 4 hours hemodialysis session a perfusion of Medialipide 20% at a rate of 0,11 g/kg/h. Medialipide will be perfused using the venous line connected to the hemodialysis machine.
  • Drug NaCl 0,9%
    Each patient will receive during a 4 hours hemodialysis session a perfusion of NACL 0,9% with a volume corresponding to the one of Medialipide 20%. NaCl 0,9% will be perfused using the venous line connected to the hemodialysis machine.
  • Biological Blood sample
    Serial biological sampling for the measurement of different blood concentrations : electrolytes, serum protein , albumin, renal function (urea, creatinine), hemoglobin, hematocrit, liver test, lipid test, ketone bodies, 6 uremic toxins (including IS and p-CS), sodium octanoate and decanoate.

Primary outcome measures

  • Dialytic clearance of p-CS [Time frame: until 240 minutes after haemodialysis session]
Secondary outcome measures (12)
  • Reduction fraction (RF) of p-CS [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of Indoxyl sulfate [Time frame: until 240 minutes after haemodialysis session]
  • Reduction fraction (RF) of Indoxyl sulfate [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of hippuric acid [Time frame: until 240 minutes after haemodialysis session]
  • Reduction fraction (RF) of hippuric acid [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of p-cresyl glucuronide [Time frame: until 240 minutes after haemodialysis session]
  • Reduction fraction (RF) of p-cresyl glucuronide [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of indol acetic acid [Time frame: until 240 minutes after haemodialysis session]
  • Reduction fraction (RF) of indol acetic acid [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of uric acid [Time frame: until 240 minutes after haemodialysis session]
  • Reduction fraction (RF) of uric acid [Time frame: At 240 minutes after haemodialysis session]
  • Dialytic clearance of 3-Carboxy-4-methyl-5-propyl-2-furanpropionic acid [Time frame: until 240 minutes after haemodialysis session]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hopital Edouard Herriot — Lyon

Identifiers

NCT: NCT06595680 · 69HCL23_0031 · 2023-510406-41-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗