急性肺损伤的血流动力学和血管外肺水 (HEAL)
急性肺损伤的血流动力学和血管外肺水:EVLW 目标导向治疗与标准管理治疗急性肺损伤的前瞻性随机对照多中心试验
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Oregon
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Clackamas、Oregon、美国、97015
- Kaiser Permanente Sunnyside
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Portland、Oregon、美国、97210
- Legacy Good Samaritan
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Portland、Oregon、美国、97219
- Oregon Health and Science University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
急性发作:
- PaO2/FiO2 小于或等于 300。
- 双侧浸润与正位胸片上的肺水肿一致。
- 通过气管插管或气管切开术进行正压通气的要求。
- 没有左心房高血压的临床证据可以解释肺部浸润。 如果测量,肺动脉楔压小于或等于 18 mmHg。
排除标准:
- 年龄小于 18 岁。
- 自首次满足所有纳入标准以来超过 24 小时。
- 在没有帮助的情况下损害通气能力的神经肌肉疾病,例如 C5 或更高的脊髓损伤、肌萎缩侧索硬化、吉兰-巴利综合征、重症肌无力或脊柱后凸(见附录 I.A)。
- 怀孕(有生育能力的女性需要进行阴性妊娠试验)。
- 严重的慢性呼吸道疾病(见附录 I.C)。
- 严重慢性肝病(Child-Pugh 11 - 15,见附录 I.E)
- 重量 > 160 公斤。
- 烧伤超过全身表面积的 70%。
- 估计 6 个月死亡率超过 50% 的恶性肿瘤或其他不可逆转的疾病或病症(见附录 I.A)。
- 已知的心脏或血管动脉瘤。
- 股动脉穿刺禁忌症——血小板 < 30,双侧股动脉移植物,INR > 3.0。
- 不承诺全力支持。
- 30天内参加过其他实验用药试验。
- 对静脉注射 lasix 或其载体的任何成分过敏。
- 严重 CHF 病史 - NYHA 等级 ≥ III,之前记录的 EF < 30%。
- 弥漫性肺泡出血。
- 存在反应性气道疾病(根据最近使用 MDI 的频率和数量以及控制疾病的类固醇来定义活性)。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:修改后的 FACTT(对照)
研究者的控制臂包括一个简化算法,用于 ALI 患者液体的保守管理,该算法将由 ARDSnet 组发布,基于 FACTT 试验中使用的协议。
该协议要求严格遵守 ARDSnet 通气、我们的脱机协议以及仅使用选定的血管活性 β-肾上腺素能药物,因为人们认为这些治疗的变化可能会严重混淆我们的结果。
除了危及生命的支气管痉挛对异丙托溴铵无反应外,任何一只手臂都不允许使用沙丁胺醇。
治疗支气管痉挛的医师可酌情给予异丙托溴铵。
PiCCO 将被放置在每个对照患者体内,并且每天记录两次数据。
主治医师将不知道该数据。
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目标:整体 I/O 净负 50ml/小时 引发:
呋塞米丸:
15 毫升/千克 PBW 晶体(四舍五入到最接近的 250 毫升)或 25 克白蛋白尽快。
用于测量 CVP 的患者
尽快加入 10 ml/kg PBW 晶体(四舍五入到最接近的 70ml)或 25 克白蛋白。 每次推注之前和之后以及之后 60 分钟立即进行热稀释。 如果 EVLW 在推注后 60 分钟内增加 > 2ml/kg PBW,则在下一次定期测量之前不要再推注。 该疗法适用于 map < 60 或使用升压药且测得的 GEDI 低于目标值的患者 (可单独使用或组合使用)
断奶:当使用稳定剂量的血管加压药后 MAP ≥ 60 mm/Hg 时,开始以 ≤ 4 小时的间隔将血管加压药减少大于或等于稳定剂量的 25%,以维持 MAP ≥ 60 mm/Hg。 (可单独使用或组合使用)
断奶:当使用稳定剂量的血管加压药后 MAP ≥ 60 mm/Hg 时,开始以 ≤ 4 小时的间隔将血管加压药减少大于或等于稳定剂量的 25%,以维持 MAP ≥ 60 mm/Hg。 在实验组中,血管加压药是平均动脉压 < 60 的患者的一种治疗选择
用于测量的心脏指数 < 2.5 的患者
如果出现以下情况,请停用呋塞米:
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实验性的:EVLW
当 EVLW 超过 9 ml/kg PBW 时,算法治疗开始并持续到 EVLW ≤ 9 ml/kg PBW 或拔管,以耐受的先到者为准(见图 6)。 当有足够的容积前负荷 (GEDI) 可用于实施容积收缩作为减少测量的 EVLW 而不引起伴随低灌注的手段时,开始使用速尿和容积收缩。 液体管理也受 EVLW 变化的指导。 由于输液导致 EVLW > 2ml/kg PBW 的增加会减少任何进一步的输液,直到下一次预定的测量。 我们的最终治疗目标是最大限度地将 EVLW 降低到正常范围 - 从而改善肺力学和气体交换 - 而不会导致伴随的血液动力学妥协和终末器官损伤。 通过这样做,我们认为这种算法、目标导向的治疗方法应该会改善结果。 |
目标:整体 I/O 净负 50ml/小时 引发:
呋塞米丸:
15 毫升/千克 PBW 晶体(四舍五入到最接近的 250 毫升)或 25 克白蛋白尽快。
用于测量 CVP 的患者
尽快加入 10 ml/kg PBW 晶体(四舍五入到最接近的 70ml)或 25 克白蛋白。 每次推注之前和之后以及之后 60 分钟立即进行热稀释。 如果 EVLW 在推注后 60 分钟内增加 > 2ml/kg PBW,则在下一次定期测量之前不要再推注。 该疗法适用于 map < 60 或使用升压药且测得的 GEDI 低于目标值的患者 (可单独使用或组合使用)
断奶:当使用稳定剂量的血管加压药后 MAP ≥ 60 mm/Hg 时,开始以 ≤ 4 小时的间隔将血管加压药减少大于或等于稳定剂量的 25%,以维持 MAP ≥ 60 mm/Hg。 (可单独使用或组合使用)
断奶:当使用稳定剂量的血管加压药后 MAP ≥ 60 mm/Hg 时,开始以 ≤ 4 小时的间隔将血管加压药减少大于或等于稳定剂量的 25%,以维持 MAP ≥ 60 mm/Hg。 在实验组中,血管加压药是平均动脉压 < 60 的患者的一种治疗选择
用于测量的心脏指数 < 2.5 的患者
如果出现以下情况,请停用呋塞米:
集中所有滴液和营养,以尽可能减少液体量。 静脉输液以保持静脉开放率运行。 EVLW 组:MAP > 60 且停用血管升压药 >12 小时的患者,以及测得的心脏指数 >2.5 且测得的 GEDI > 目标的患者。 |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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主要疗效变量将是测量的肺水的总减少量
大体时间:治疗的前 7 天
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治疗的前 7 天
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合作者和调查者
调查人员
- 首席研究员:Charles Phillips, M.D.、Oregon Health and Science University
出版物和有用的链接
一般刊物
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- IRB00003491
- IRB #e2978
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