A study comparing medium-chain triglycerides and sodium chloride infusions during hemodialysis to improve toxin removal in patients with chronic kidney disease

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What is this study about?

This clinical trial focuses on patients with chronic hemodialysis who have been receiving treatment for more than 3 months and have no remaining urine production. The study aims to test a new method to improve the removal of harmful substances from the blood during dialysis treatment. The main focus is on improving the removal of a substance called p-cresyl sulfate, which is typically difficult to remove during regular dialysis sessions.

The study will compare two different approaches during dialysis sessions: one using Medialipide, which is a special fat-based solution containing medium-chain triglycerides and soya oil, and another using standard sodium chloride solution (salt water). Each dialysis session in the study will last for 4 hours, during which these solutions will be given through an intravenous line.

During the treatment, researchers will measure how effectively the dialysis removes various harmful substances from the blood. They will also monitor the safety of using Medialipide by checking for side effects such as nausea, vomiting, headaches, and by measuring blood levels of fats and liver function. Blood samples will be taken at different times during the dialysis session to measure the levels of various substances.

1 Initial hemodialysis session

You will undergo a standard hemodialysis session lasting 4 hours

During this session, you will receive an infusion of either Medialipide (a fatty acid solution) or saline solution

Blood samples will be taken from the dialysis machine at the start of the session

2 Monitoring during session

Throughout the 4-hour session, medical staff will collect samples from your blood and dialysis fluid

Your condition will be monitored for any signs of discomfort such as nausea, vomiting, or headache

3 End of session measurements

At the end of the 4-hour session, final blood samples will be taken

Your triglyceride levels (fat levels in blood) will be measured

Additional blood tests will check your liver function

4 Follow-up session

After a period of time, you will undergo a second 4-hour dialysis session

This session will be identical to the first, but with the alternative solution (either Medialipide or saline)

The same measurements and monitoring will be performed as in the first session

5 Final assessment

Your blood test results will be analyzed to measure the effectiveness of both treatment methods

The medical team will evaluate how well different waste products were removed from your blood during each session

Who Can Join the Study?

Must be 18 years or older
Must be receiving hemodialysis treatment (a procedure that filters waste and excess fluid from blood) three times per week, with each session lasting 4 hours, for at least 3 months
Must have no residual urine production (less than 100 mL per day)
For women who can become pregnant:
- Must use highly effective contraception throughout the study duration
- Acceptable methods include:
  - Complete sexual abstinence
  - Combined hormonal contraception
  - Bilateral tubal ligation (surgical blocking of fallopian tubes)
- Must undergo a pregnancy blood test (beta-HCG) when joining the study
Must be enrolled in a social security program
Must be able to provide written informed consent to participate in the study

Who Cannot Join the Study?

Patients who have been on hemodialysis for less than 3 months
Patients who have residual urine output more than 100 mL per day (residual diuresis – remaining ability to produce urine)
Children and adolescents under 18 years of age
Pregnant or breastfeeding women
Patients with known allergies to medium-chain fatty acids (type of fats used in the study medication)
Patients who cannot provide informed consent
Patients participating in other clinical trials
Patients with severe heart, liver, or blood disorders
Patients with active infections
Patients with unstable medical conditions that could interfere with the study procedures

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	31.12.2024

Trial locations

Investigated drugs:

Medialipide is a medium-chain fatty acid emulsion used during hemodialysis treatment. It is administered through infusion during dialysis sessions to help improve the removal of harmful toxins from the blood, particularly substances called protein-bound uremic toxins. This medication works by helping to separate these toxins from proteins in the blood, making them easier to remove during the dialysis process.

Saline is a sterile solution of salt water that is commonly used in medical procedures. In this trial, it serves as a comparison treatment, being infused during hemodialysis sessions to compare its effectiveness against Medialipide in removing toxins from the blood.

End-Stage Renal Disease with Chronic Hemodialysis Dependence – A condition where the kidneys have permanently lost their ability to function, requiring regular hemodialysis treatments to filter waste products from the blood. This condition develops when kidney function deteriorates to the point where natural filtration becomes insufficient, leading to the accumulation of toxins and waste products in the blood. In this specific state, patients produce virtually no urine (less than 100mL per day) and have been receiving dialysis for more than 3 months. The body cannot maintain proper fluid and electrolyte balance without external support, and various uremic toxins, including p-cresyl sulfate and indoxyl sulfate, build up between dialysis sessions.

Trial ID:

2023-510406-41-00

Protocol code:

69HCL23_0031

Trial Phase:

Therapeutic exploratory (Phase II)

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A study comparing medium-chain triglycerides and sodium chloride infusions during hemodialysis to improve toxin removal in patients with chronic kidney disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?