Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 27
- 主要终点
- Percent Change in Oxygen Saturation (SpO2) From Baseline
研究概览
简要总结
Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical evidence of pulmonary hypertension (PH) requiring INO therapy as prescribed by the attending physician.
- •Indwelling arterial catheter.
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Inhaled Iloprost (Drug)
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.
干预措施: Inhaled Iloprost (Drug)
结局指标
主要结局
Percent Change in Oxygen Saturation (SpO2) From Baseline
时间窗: 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
时间窗: 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
时间窗: 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: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline
时间窗: dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
次要结局
- Change in Cardiac Output (CO) From Baseline(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(dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour))