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Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors: randomized controlled clinical trial "CANREO-PMO"

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513809-31-00
Acronym
2019PI117
Enrollment
36
Registered
2024-08-27
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain-dead Organ Donors

Brief summary

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.

Detailed description

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,, Objective 2 : The percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : The vital status of kidney recipients from these donors at 3 months, 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.

Interventions

DRUGSOLUDACTONE 200 mg
DRUGlyophilisat et solution pour usage parentéral
DRUGCHLORURE DE SODIUM 0

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
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,, Objective 2 : The percentage of patients dependent on dialysis and / or with an estimated GFR <20 mL / min / 1.73m² at 3 months, Objective 3 : The vital status of kidney recipients from these donors at 3 months, 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.

Primary

MeasureTime frame
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.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026