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Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors
EU CTIS ID: 2024-513809-31-00
What this study is testing
To assess the impact of potassium canrenoate administration vs. placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting (including renal).
- 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
- Men, women aged 18 years or older;
- Encephalic death diagnosed either by 2 flat and areactive 30-minute electroencephalograms performed 4 hours apart or by a cerebral CT angiography showing a non-opacification of the cortical middle cerebral arteries and internal cerebral veins
- And from whom an harvesting of one or both kidneys is envisaged (within 6 hours or more), according to the procedures currently in force at the Agence de la Biomédecine;
- Dose of vasopressor agent that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor pressure less than 7 mg / h at inclusion;
- Euvolemic patient at inclusion;
- Affiliated to Social Security scheme;
You likely can't join if
- Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study
- Severe atrioventricular conduction disorders
- Terminal stage of hepatocellular insufficiency;
- Persons referred to in articles L. 1121-5, L.1121-6, L. 1121-7 and L1121-8 of France's public health code: -Pregnant, parturient or lactating woman; -Persons deprived of their liberty by a judicial or administrative decision; -Minors (non emancipated); -Adults subject to legal protection measures (guardianship, curatorship, safeguard of justice); -Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the Public Health Code.
- Patient on long-term mineralocorticoid receptor antagonist (eplerenone or spironolactone);
- Having a serum potassium concentration> 5.5 mmol / L on inclusion;
See the full eligibility criteria
- Men, women aged 18 years or older;
- Encephalic death diagnosed either by 2 flat and areactive 30-minute electroencephalograms performed 4 hours apart or by a cerebral CT angiography showing a non-opacification of the cortical middle cerebral arteries and internal cerebral veins
- And from whom an harvesting of one or both kidneys is envisaged (within 6 hours or more), according to the procedures currently in force at the Agence de la Biomédecine;
- Dose of vasopressor agent that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor pressure less than 7 mg / h at inclusion;
- Euvolemic patient at inclusion;
- Affiliated to Social Security scheme;
- Signed written consent by the support person provided for in article L. 1111-6, or failing this by a family member.
- Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study
- Severe atrioventricular conduction disorders
- Terminal stage of hepatocellular insufficiency;
- Persons referred to in articles L. 1121-5, L.1121-6, L. 1121-7 and L1121-8 of France's public health code: -Pregnant, parturient or lactating woman; -Persons deprived of their liberty by a judicial or administrative decision; -Minors (non emancipated); -Adults subject to legal protection measures (guardianship, curatorship, safeguard of justice); -Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the Public Health Code.
- Patient on long-term mineralocorticoid receptor antagonist (eplerenone or spironolactone);
- Having a serum potassium concentration> 5.5 mmol / L on inclusion;
- Contraindications to multi-organ removal (infectious, neoplastic causes, etc.);
- Refusal of organ removal expressed by the patient (national register of refusals or reported by the family);
- Probable inability to remove the kidneys: history of urine-renal disease, pre-existing chronic renal failure, morphological abnormalities of the kidneys, renal trauma;
- Patients included in another interventional drug clinical trial;
- Known potassium canrenoate and / or trometamol hypersensitivity;
- Severe renal failure;
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.