Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors

Phase 1

Active, not recruiting

• Conditions: hemodynamic of patients in a state of cerebral death candidate for renal or multiple organ removal (including kidney); MedDRA version: 21.0Level: PTClassification code 10058985Term: Organ donorSystem Organ Class: 10041244 - Social circumstances; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2020-003285-40-FR
• Lead Sponsor: CHRU de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-20
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

•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 included in another interventional drug clinical trial;
•Known potassium canrenoate and / or trometamol hypersensitivity;
•Severe renal failure;
•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified