NCT03718312已完成不适用
Evaluation of the Effectiveness of Ischemic Pre-conditioning on the Morbidity and Mortality of Open Surgery of Thoracoabdominal Aortic Aneurysms.
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2019年7月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- occurrence of a kidney complication
研究概览
简要总结
Patients having a planned open surgery of thoracoabdominal aortic aneurysms and enrolled in the study will be randomized the day of the surgery in 2 groups:
- Arm 1 : Patients with aortic clamping with pre-conditioning
- Arm 2 : Patients with aortic clamping without pre-conditioning Patients will be then followed, during 60 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient > 18 and <85 years old
- •Patient having a planned surgery for a thoracoabdominal aortic aneurysm by direct approach,
- •Patient with aortic aneurysm requiring supra-visceral aortic clamping and visceral artery reconstruction,
- •Aortic aneurysmal patient with or without distal femoral circulatory assistance,
- •Patient with aortic aneurysm of atheromatous or dissecting etiology,
- •Woman of childbearing potential with effective contraception (estrogen-progestin or intrauterine device or tubal ligation), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
- •Patient who read and understood the newsletter and signed the consent form
- •Patient affiliated with a social security scheme
排除标准
- •Patient with aortic aneurysms requiring supra-visceral aortic clamping but not requiring visceral artery reconstruction (supra-visceral aortic clamping for renal aortic juxtaposition aorta),
- •Patient with thoraco abdominal aortic aneurysms requiring a circulatory arrest (aortic aneurysms affecting the descending thoracic aorta or the aortic arch)
- •Patient requiring emergency aortic surgery
- •Patient under treatment known as interfering with PCI (Nicorandil or oral antidiabetic agents),
- •Pregnant or lactating woman (negative result of baseline blood test)
- •Participation in another interventional study within 28 days before randomization or during this study
- •Person deprived of liberty by an administrative or judicial decision or person subject to a legal measure for the protection of adults,
- •Patient under the protection of justice, patient under guardianship or curatorship.
结局指标
主要结局
occurrence of a kidney complication
时间窗: During the 8 days after surgery
According to RIFLE criteria
occurrence of a pulmonary complication
时间窗: During the 48 hours after initial extubation
Need for a new ventilation (invasive or not)
次要结局
- Pulmonary Morbidity(During the 21 days after surgery)
- Kidney Morbidity(During the 21 days after surgery)
- Cardiac Morbidity(During the 48 hours after surgery)
- cell and tissue damage(During the 8 days after surgery)
- Death(During 60 days after surgery)
研究者
研究点 (2)
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