POTASSIUM CANRENOATE, TROMETAMOL for Brain death (organ donors)

Inclusion criteria

• {"criterion_text":"- Men, women aged 18 years or older;"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- 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;"}
• {"criterion_text":"- Euvolemic patient at inclusion;"}
• {"criterion_text":"- Affiliated to Social Security scheme;"}
• {"criterion_text":"- Signed written consent by the support person provided for in article L. 1111-6, or failing this by a family member."}

Exclusion criteria

• {"criterion_text":"- Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study"}
• {"criterion_text":"- Severe atrioventricular conduction disorders"}
• {"criterion_text":"- Terminal stage of hepatocellular insufficiency;"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient on long-term mineralocorticoid receptor antagonist (eplerenone or spironolactone);"}
• {"criterion_text":"- Having a serum potassium concentration> 5.5 mmol / L on inclusion;"}
• {"criterion_text":"- Contraindications to multi-organ removal (infectious, neoplastic causes, etc.);"}
• {"criterion_text":"- Refusal of organ removal expressed by the patient (national register of refusals or reported by the family);"}
• {"criterion_text":"- Probable inability to remove the kidneys: history of urine-renal disease, pre-existing chronic renal failure, morphological abnormalities of the kidneys, renal trauma;"}
• {"criterion_text":"- Patients included in another interventional drug clinical trial;"}
• {"criterion_text":"- Known potassium canrenoate and / or trometamol hypersensitivity;"}
• {"criterion_text":"- Severe renal failure;"}

Primary endpoints

• {"endpoint_text":"- Hierarchical composite of events including in descending order:A. Cardio circulatory arrest before organ removal, B. the inability to perform the renal swab (since the anticipated effectiveness of the canrenoate would mainly relate to this organ), C. the average hourly dose of noradrenaline / adrenaline between randomisation and departure to the operating room, D. the average hourly volume of crystalloids and / or colloids used between randomization and departure to the operating room.","definition_or_measurement_approach":"Hierarchical composite endpoint with components: A) cardio circulatory arrest before organ removal; B) inability to perform renal harvest; C) mean hourly dose of noradrenaline/adrenaline between randomisation and departure to OR; D) mean hourly volume of crystalloids and/or colloids used between randomisation and departure to OR."}

Secondary endpoints

• {"endpoint_text":"- Secondary objectifs will be evaluated by consulting data from the CRISTAL database : Objective 1 : the vital status and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 3 months after kidney transplant,","definition_or_measurement_approach":"Evaluated via the CRISTAL database: vital status and serum creatinine (μmol/L) with GFR estimated by CKD-EPI at 3 months post-transplant."}
• {"endpoint_text":"- Objective 2 : The percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months","definition_or_measurement_approach":"Proportion of recipients dependent on dialysis and/or with estimated GFR <20 mL/min/1.73m2 at 3 months (CRISTAL database)."}
• {"endpoint_text":"- Objective 3 : The vital status of kidney recipients from these donors at 3 months","definition_or_measurement_approach":"Vital status of kidney recipients at 3 months post-transplant (CRISTAL database)."}
• {"endpoint_text":"- Objective 4 : The vital status of kidney recipients from these donors and serum creatinine (in μmol / L) with estimation of the glomerular filtration rate (GFR) according to CKD-EPI (in mL / min / 1.73m2), 1 year, 3 years, and 10 years from transplant.","definition_or_measurement_approach":"Vital status and serum creatinine with CKD-EPI estimated GFR at 1, 3, and 10 years post-transplant (CRISTAL database)."}

France

Earliest CTIS Part Ii Submission Date

23-07-2024

Latest Decision Or Authorization Date

27-08-2024

Processing Time Days

35

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

CHRU De Nancy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France