jRCT1031250780招募中不适用
A Prospective Exploratory Clinical Study Evaluating the Efficacy and Safety of the INOFlo System in Cases of Cardiogenic Shock Under Impella Support
未提供0 个研究点目标入组 16 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Individuals with cardiogenic shock under hemodynamic support with Impella.
- •(2) Individuals within 5 days of initiating Impella support and not yet introduced to nitric oxide therapy.
- •(3) Individuals with a pulmonary artery catheter inserted.
- •(4) Individuals with pulmonary hypertension (mean pulmonary artery pressure >= 21 mmHg and PVR >= 2 Wood units).
- •(5) Age: Individuals aged >= 18 years at the time of informed consent.
- •(6) Gender: Not specified.
- •(7) Individuals who have provided voluntary written informed consent (by themselves or a legal representative) after receiving sufficient explanation and achieving full understanding for participation in this study
排除标准
- •(1) Individuals in whom ECMO or IMPELLA does not function stably due to factors other than right ventricular afterload.
- •(2) Individuals with persistent severe hypotension with mean arterial pressure < 50 mmHg even under ECPELLA support.
- •(3) Individuals with severe hepatic impairment, renal impairment, or cardiovascular disease (determined with reference to Grade 3 of JCOG CTCAE version 5.0).
- •(4) Individuals undergoing or requiring prohibited concomitant therapies.
- •(5) Others judged inappropriate for participation in this study by the investigator or sub-investigator.
研究者
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