2024-513809-31-00招募中2 期
Evaluation of the hemodynamic tolerance of potassium canrenoate in brain-dead organ donors: randomized controlled clinical trial "CANREO-PMO"
CHRU De Nancy1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年8月27日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
To assess the impact of potassium canrenoate administration vs. placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting (including renal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Long Term folllowed up (up to 10 years) of Graft recipients from donors randomised
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patient having received potassium canrenoate in the 48 hours preceding inclusion in the study
- •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.
- •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;
结局指标
主要结局
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.
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.
次要结局
- 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.
研究者
Philippe GUERCI
Scientific
CHRU De Nancy
研究点 (1)
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