Study on the Effects of Potassium Canrenoate and Trometamol on Blood Flow in Brain-Dead Organ Donors

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What is this study about?

This clinical trial is focused on evaluating the effects of a medication called potassium canrenoate on individuals who are brain-dead and are potential organ donors. The study aims to understand how this medication affects the heart and blood circulation in these individuals. Potassium canrenoate is administered as a solution for injection, and it is compared to a placebo to assess its impact.

The trial involves participants who are brain-dead and are candidates for organ donation, specifically for kidney or multiple organ harvesting. During the study, participants will receive either potassium canrenoate or a placebo, and their heart and blood circulation will be monitored to see how they respond to the treatment. The study will also use a solution called sodium chloride as part of the infusion process.

The purpose of this study is to gather information on the safety and effectiveness of potassium canrenoate in maintaining stable heart and blood circulation in brain-dead organ donors. The results will help determine if this medication can improve the conditions for organ donation and potentially benefit recipients of these organs. The study will continue to monitor the health of organ recipients for several years after the transplant to assess long-term outcomes.

1 joining the study

Participation begins after meeting specific criteria, including age and medical condition requirements.

Consent is obtained from a designated support person or family member.

2 randomization

Participants are randomly assigned to receive either potassium canrenoate or a placebo.

This process ensures unbiased results in evaluating the effects of the medication.

3 medication administration

The medication, potassium canrenoate, is administered intravenously as a solution for injection.

A sodium chloride solution is also used for infusion during the trial.

4 monitoring and evaluation

Participants are closely monitored for changes in hemodynamics, which refers to the blood flow and circulation within the body.

The primary focus is on the impact of the medication on the cardiovascular system before organ removal.

5 data collection

Data is collected on various outcomes, including the occurrence of cardio circulatory arrest and the ability to perform organ removal.

Additional data includes the average hourly dose of noradrenaline/adrenaline and the volume of fluids used.

6 follow-up

Secondary objectives are assessed by reviewing data from the CRISTAL database.

This includes evaluating the health status of kidney recipients at intervals of 3 months, 1 year, 3 years, and 10 years post-transplant.

Who Can Join the Study?

Men and women who are 18 years or older.
Individuals who have been diagnosed with encephalic death. This means the brain has stopped functioning, confirmed by either two tests showing no brain activity or a special brain scan showing no blood flow in certain brain areas.
Individuals from whom one or both kidneys are planned to be taken for donation, following the current procedures.
The dose of vasopressor agent (a medicine that helps maintain blood pressure) should not have changed by more than 1 mg per hour in the hour before joining the study, and the dose should be less than 7 mg per hour at the time of joining.
The patient should be euvolemic at the time of joining, meaning they have a normal amount of body fluids.
The patient must be affiliated with a Social Security scheme.
A signed written consent must be provided by a support person or a family member, as required by the regulations.

Who Cannot Join the Study?

Individuals who are not brain-dead. This means the person must have no brain activity and be declared brain-dead.
Individuals who are not candidates for organ donation. This means the person must be considered for donating organs like kidneys.
Individuals who are not within the specified age range. The study is only for certain age groups.
Individuals who do not meet the gender requirements. Both males and females are eligible, but specific criteria may apply.
Individuals who are not part of a vulnerable population. This refers to groups that may need special protection or consideration.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Cxvf Dl Navti	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	26.08.2021

Trial locations

Investigated drugs:

Potassium Canrenoate is a medication being studied for its effects on the heart and blood circulation in individuals who are brain-dead and potential organ donors. The trial aims to understand how this medication might help maintain stable blood flow and heart function in these individuals, which is important for the success of organ donation.

Investigated diseases:

Organ donor

Brain Death – Brain death is a condition where there is a complete and irreversible loss of brain function, including the brainstem. It is considered a legal definition of death in many jurisdictions. The condition occurs when the brain is deprived of oxygen for an extended period, leading to the cessation of all neurological activity. Despite the heart continuing to beat with mechanical support, the individual cannot breathe independently. Brain death is distinct from a coma or vegetative state, as there is no possibility of recovery. It is often a consideration in organ donation, as the body can be maintained on life support for organ preservation.

Trial ID:

2024-513809-31-00

Protocol code:

2019PI117

NCT ID:

NCT04714710

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Potassium Canrenoate and Trometamol on Blood Flow in Brain-Dead Organ Donors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?