Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
研究概览
详细说明
Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.
Phase 2 - All remaining subjects received Iloprost as a continuous treatment.
The study was designed for an enrollment of 200 subjects and was ended early.
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
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
有资格学习的性别
描述
Inclusion Criteria:
- Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
- Indwelling arterial catheter.
- Signed informed consent
Exclusion Criteria:
- Clinically unstable circulatory condition requiring epinephrine > 0.1 mcg/kg/min or levophed, or already meeting treatment failure criteria (see section 5.3 below)
- Known hypersensitivity to prostacyclin compounds
- Patients receiving sildenafil or bosentan
- Refusal by the attending physician
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phase 2: Inhaled Iloprost continuous
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. |
A 20 mcg dose of Iloprost will be given initially.
其他名称：
|
|
实验性的：Phase 1: Inhaled Iloprost 3 doses
Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made. A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose. |
A 20 mcg dose of Iloprost will be given initially.
其他名称：
|
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 |
|---|---|---|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
大体时间：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
Readings were taken from the medical record and the data may not have been present at the exact time frames.
|
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
|
Percent Change in Oxygen Saturation (SpO2) From Baseline
大体时间：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
|
|
Change in Mean Heart Rate From Baseline
大体时间：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
|
|
Change in Mean Heart Rate From Baseline
大体时间：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
|
|
Number of Treatment Failures
大体时间：as long as subject was on drug up to approximately 24 hours
|
Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:
|
as long as subject was on drug up to approximately 24 hours
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
大体时间：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
|
|
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
大体时间：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Cardiac Output (CO) From Baseline
大体时间：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
|
|
Change in Cardiac Output (CO) From Baseline
大体时间：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
大体时间：30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
|
30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
|
|
Change in Mean Venous Oxygen Saturation (SvO2) From Baseline
大体时间：dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
|
合作者和调查者
调查人员
- 首席研究员：Neil MacIntyre, MD、Duke University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.