Status:
ACTIVE_NOT_RECRUITING
Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
Lead Sponsor:
Pr. Nicolas GIRERD
Conditions:
Brain-dead Organ Donors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Given the current organ shortage, improving the quality/efficacy of harvested grafts from expanded criteria donors is essential to substantially increase the number of potential donors. Preclinical st...
Detailed Description
In this single-center, double-blind, placebo-controlled clinical trial, we seek to evaluate the effect of the administration of 200 mg of IV potassium canrenoate vs placebo in brain-dead donors aged 1...
Eligibility Criteria
Inclusion
- 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 angioTDM objectifying a total cessation of intracranial circulation,
- And from whom a removal 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,
- Dosage of vasopressor agent amines that have not varied by more than 1 mg/h in the hour preceding inclusion and dose of vasopressor less than 7 mg / h at inclusion,
- euvolemic donor patient at inclusion,
- Benefiting from a Social Security affiliation scheme.
- Signature of consent by a family member or the support person.
Exclusion
- Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study,
- 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 enrolled in another interventional drug trial,
- Person with a contraindication to potassium canrenoate and/or trometamol,
- Severe renal failure,
- Severe atrioventricular conduction disorders,
- Terminal stage of hepatocellular failure,
- 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 french Public Health Code
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2033
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04714710
Start Date
August 26 2021
End Date
December 6 2033
Last Update
July 3 2025
Active Locations (1)
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1
CHRU de NANCY
Nancy, France, 54500