BridgeMD
CLEARTOX: Development of an innovative haemodialysis method to improve dialytic clearance of protein-bound uraemic toxins
EU CTIS ID: 2023-510406-41-00
What this study is testing
Compare the clearance of p-cresyl sulfate during dialysis (from H0 to H4) between a hemodialysis session with infusion of a medium-chain fatty acid emulsion (Medialipide®) and a hemodialysis session with infusion of saline.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- On hemodialysis at a frequency of 3 4-hour sessions per week (+/- 30 minutes), for at least 1 month
- 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.
- Patient affiliated to a social security scheme
- Free, informed and written consent signed by the patient
You likely can't join if
- Residual diuresis > 100 mL per day
- Patients with unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin)
- Patients in the acute phase of myocardial infarction or stroke
- Pregnant or breastfeeding
- Patients with uncorrected disturbances of fluid and electrolyte balance, such as hypokalemia and hypotonic dehydration
- Patients with decompensated heart failure
See the full eligibility criteria
- Age ≥18 years
- On hemodialysis at a frequency of 3 4-hour sessions per week (+/- 30 minutes), for at least 1 month
- 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.
- Patient affiliated to a social security scheme
- Free, informed and written consent signed by the patient
- Residual diuresis > 100 mL per day
- Patients with unstable metabolic conditions (e.g. severe post-traumatic syndrome, coma of unknown origin)
- Patients in the acute phase of myocardial infarction or stroke
- Pregnant or breastfeeding
- Patients with uncorrected disturbances of fluid and electrolyte balance, such as hypokalemia and hypotonic dehydration
- Patients with decompensated heart failure
- patients with acute pulmonary edema
- 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.
- Uncontrolled hypertension > 180/115 mmHg
- Perdialytic hypotension requiring vascular filling > 100 mL during the last 3 sessions
- Patient already on parenteral nutrition
- Patients with sepsis < 1 month
- Patient already on antivitamin K (or prescribed less than one month prior to inclusion)
- Patient with heparin allergy or requiring hemodialysis without anticoagulant (recent hemorrhage)
- 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®
- Patients with severe hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia > 3 mmol/l
- Patients on non-steroidal anti-inflammatory drugs
- Patients under legal protection
- Persons incapable of expressing their consent
- Persons deprived of their liberty and emergency situations.
- Patient with severe liver failure or cholestasis
- Patient with known severe coagulopathy
- Patient with acute thromboembolic events
- Patient with fat embolism
- Patient with an aggravating bleeding diathesis
- Patient with uncompensated metabolic acidosis
- Patient with an unstable circulatory state threatening the vital prognosis (collapse and shock)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.