A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics
2019年7月11日 更新者：Shenzhen Second People's Hospital
The purpose of this study was to evaluate the curative effect of Levosimendan on ARDS patients through omni-directional and multi-angle objective quantitative indexes, and to study the responsiveness of ARDS with or without right ventricular insufficiency to the treatment of Levosimendan, and to indirectly confirm whether Levosimendan had lung protective mechanism other than calcium sensitization to ARDS patients, such as inhibiting inflammatory reaction to reduce pulmonary capillary leakage and alveolar epithelial cell injury.
Relaxation of bronchial smooth muscle improves pulmonary ventilation function.
To provide new methods and ideas for clinical treatment of ARDS.
研究概览
详细说明
On the basis of the above research, the investigators speculate that Levosimendan can improve cardiac function, enhance diaphragm contractility and decrease pulmonary artery through this sensitizing effect, and protect ARDS lung function by regulating the release and oxidation of inflammatory mediators and nitroso oxidative stress.
The hemodynamic and pulmonary protective effects of ARDS patients were improved by regulating K-ATP channels, relieving blood vessels and bronchospasm and improving ventilation and diffusion function in ARDS patients, so as to further improve the survival rate of these patients and shorten the mechanical ventilation time and ICU stay time.
The purpose of this study was to observe the effect of Levosimendan on pulmonary circulation and right ventricular function in patients with ARDS, to determine whether it can reduce the fatality rate of ARDS and shorten its ICU residence time, and to evaluate the evaluation of ARDS with or without right ventricular insufficiency and to provide a new idea and method for drug treatment of ARDS.
研究类型
介入性
注册 (预期的)
120
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Guangdong
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Shenzhen、Guangdong、中国
- 招聘中
- Shenzhen Second People's Hospital
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接触：
- Nie Guohui, doctor
- 电话号码：0755-83366388
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接触：
- Xie Ni
- 电话号码：0755-83366388
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Clinical diagnosis of ARDS; joined this study with informed consents
Exclusion Criteria:
neurological and muscle diseases; Chronic severe liver and kidney failure; advanced malignant tumor; Primary left ventricular insufficiency;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Routine treatment
Routine treatment group: control infection, remove or control the primary disease; mechanical ventilation with low tidal volume and high PEEP mechanical ventilation strategy; strictly control volume, strengthen airway management, timely nutritional support and severe rehabilitation treatment.
|
General treatment group: control the infection, remove or control the original disease, mechanical ventilation, small tidal volume, high PEEP mechanical ventilation strategy, strictly control the capacity, strengthen the airway management, timely nutrition support and intensive rehabilitation treatment.
Levosimendan group: on the basis of routine group treatment, 12.5 mg of levosimendan 5% GS 50ml was given on the same day, and the micro-pump was continuously pumped for 24 hours.
The initial dose was 0.5 ml/ h, and if the blood pressure was not significantly decreased, the blood pressure was gradually increased to 2.4 ml/ h at the maximum dose, until the pump was over.
The above treatment is repeated every 7 days until the offline success or the patient leaves the ICU.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
APACHE II score
大体时间：Admission for 24 hours
|
The lowest value in the first 24 hours after entering ICU.
The total score is 0~71 points.
The higher the score, the more serious the disease
|
Admission for 24 hours
|
|
SOFA score
大体时间：Admission for 7 days
|
The total score is 0~48 points.
The higher the score, the more serious the disease
|
Admission for 7 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mechanical ventilation time
大体时间：From admission to 30 days
|
how long did the patient stay in ICU
|
From admission to 30 days
|
|
mecical expense
大体时间：From admission to 30 days
|
how much did the patient cost.
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From admission to 30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Feng yongwen, master、Shenzhen Second People's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wang Q, Yokoo H, Takashina M, Sakata K, Ohashi W, Abedelzaher LA, Imaizumi T, Sakamoto T, Hattori K, Matsuda N, Hattori Y. Anti-Inflammatory Profile of Levosimendan in Cecal Ligation-Induced Septic Mice and in Lipopolysaccharide-Stimulated Macrophages. Crit Care Med. 2015 Nov;43(11):e508-20. doi: 10.1097/CCM.0000000000001269.
- Gordon AC, Perkins GD, Singer M, McAuley DF, Orme RM, Santhakumaran S, Mason AJ, Cross M, Al-Beidh F, Best-Lane J, Brealey D, Nutt CL, McNamee JJ, Reschreiter H, Breen A, Liu KD, Ashby D. Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis. N Engl J Med. 2016 Oct 27;375(17):1638-1648. doi: 10.1056/NEJMoa1609409. Epub 2016 Oct 5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年7月1日
初级完成 (预期的)
2021年12月30日
研究完成 (预期的)
2022年8月30日
研究注册日期
首次提交
2019年7月2日
首先提交符合 QC 标准的
2019年7月11日
首次发布 (实际的)
2019年7月15日
研究记录更新
最后更新发布 (实际的)
2019年7月15日
上次提交的符合 QC 标准的更新
2019年7月11日
最后验证
2019年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 20193357016
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data for all primary and secondary outcome measures will be available.
IPD 共享时间框架
Date will be available within 6 months of study completion
IPD 共享访问标准
Date assess requests will be reviewed by an external Independent Review Panel.
Requestors will be required to sign a Data Access Agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
研究数据/文件
-
个人参与者数据集
信息标识符：mengxinke
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ARDS，人类的临床试验
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Assistance Publique - Hôpitaux de Paris尚未招聘
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Southeast University, ChinaFirst Affiliated Hospital of Wannan Medical College完全的
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Affiliated Hospital of Qinghai UniversityChildren's Hospital of Fudan University未知
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University Hospital, Clermont-FerrandUniversity Hospital, Estaing未知
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Guy's and St Thomas' NHS Foundation Trust招聘中
Levosimendan的临床试验
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Ain Shams University完全的