Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
- Conditions
- Brain-dead Organ Donors
- Registration Number
- NCT04714710
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria:<br><br> - Men, women aged 18 years or older,<br><br> - Encephalic death diagnosed either by 2 flat and areactive 30-minute<br> electroencephalograms performed 4 hours apart or by a cerebral angioTDM objectifying<br> a total cessation of intracranial circulation,<br><br> - And from whom a removal of one or both kidneys is envisaged (within 6 hours or<br> more), according to the procedures currently in force at the Agence de la<br> Biomédecine,<br><br> - Dosage of vasopressor agent amines that have not varied by more than 1 mg/h in the<br> hour preceding inclusion and dose of vasopressor less than 7 mg / h at inclusion,<br><br> - euvolemic donor patient at inclusion,<br><br> - Benefiting from a Social Security affiliation scheme.<br><br> - Signature of consent by a family member or the support person.<br><br>Exclusion Criteria:<br><br> - Patient having received potassium canrenoate in the 48 hours preceding inclusion in<br> the study,<br><br> - Patient on long-term mineralocorticoid receptor antagonist (eplerenone or<br> spironolactone),<br><br> - Having a serum potassium concentration> 5.5 mmol / L on inclusion,<br><br> - Contraindications to multi-organ removal (infectious, neoplastic causes, etc.),<br><br> - Refusal of organ removal expressed by the patient (national register of refusals or<br> reported by the family),<br><br> - Probable inability to remove the kidneys: history of urine-renal disease,<br> pre-existing chronic renal failure, morphological abnormalities of the kidneys,<br> renal trauma,<br><br> - Patients enrolled in another interventional drug trial,<br><br> - Person with a contraindication to potassium canrenoate and/or trometamol,<br><br> - Severe renal failure,<br><br> - Severe atrioventricular conduction disorders,<br><br> - Terminal stage of hepatocellular failure,<br><br> - Pregnant, parturient or lactating woman,<br><br> - Persons deprived of their liberty by a judicial or administrative decision,<br><br> - Minors (non emancipated)<br><br> - Adults subject to legal protection measures (guardianship, curatorship, safeguard of<br> justice).<br><br> - Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the french<br> Public Health Code
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Donor death (cardio circulatory arrest);Inability to perform kidney harvest;The average hourly dose of norepinephrine or epinephrine;The average hourly volume of crystalloids and / or colloids
- Secondary Outcome Measures
Name Time Method Mortality rate of the kidney recipients;Serum creatinine (in µmol / L) of kidney recipients;Percentage of kidney recipients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m²