2025-525153-39-00招募中3 期
Effect of vasopressin versus norepinephrine on post-operative mean pulmonary arterial pressure following pulmonary endarterectomy surgery, a randomized open label trial
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
To compare the efficacy of vasopressin versus norepinephrine on the immediate post-operative reduction in mean pulmonary arterial pressure (mPAP) following pulmonary artery endarterectomy.
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
- 否
入选标准
- •Age ≥18 years;
- •Patient scheduled for pulmonary endarterectomy surgery;
- •In women of childbearing potential: negative serum pregnancy test and use of adequate contraception;
- •Affiliation to the French social care service;
- •Patient able to understand and sign a written informed consent form.
排除标准
- •Emergency surgery;
- •Mesenteric ischemia and/or acute coronary syndrome within the month preceding the intervention;
- •Known allergy to the active substance vasopressin or to any of its excipients;
- •Concomitant coronary bypass procedure or other combined surgery (i.e. valve replacement);
- •mPAP<25 mmHg on preoperative right heart catheterization;
- •Patient participating to another interventional clinical trial;
- •For females only: documented pregnancy or lactation;
- •Patient under tutorship, curatorship or legal protection
- •Patient deprived of liberty.
研究组 & 干预措施
Reverpleg 40 U.I./2 ml solution à diluer pour perfusion
Test
干预措施: Reverpleg 40 U.I./2 ml solution à diluer pour perfusion (Drug)
NORADRENALINE VIATRIS 2 mg/ml SANS SULFITES, solution à diluer pour perfusion
Comparator
干预措施: NORADRENALINE VIATRIS 2 mg/ml SANS SULFITES, solution à diluer pour perfusion (Drug)
研究者
Dr. Sylvain DIOP
Scientific
Fondation Hopital Saint Joseph
研究点 (1)
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