A Pilot Study of Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determining improvement in pulmonary artery pressure in response to iNO
研究概览
简要总结
Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ARDS based on the Berlin criteria
- •Mechanically ventilated
- •Age ≥ 18 years
排除标准
- •Primary cardiogenic shock
- •History of more than mild pulmonary hypertension preceding ARDS diagnosis
- •Presence of pre-existing significant valvular disease
- •Presence of pre-existing left ventricular dysfunction or significant hypertrophy
- •Consent cannot be obtained from the patient or his/her surrogates
- •Refusal of consent
- •Opinion of treating physicians that enrolling the patient in the study would be detrimental to his/her outcome
研究组 & 干预措施
iNOMAX
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Determining improvement in pulmonary artery pressure in response to iNO
时间窗: Approximately 4 days
Pulmonary artery systolic pressure (in mmHg) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in tricuspid annular plane systolic excursion in response to iNO
时间窗: Approximately 4 days
Changes in tricuspid annular plane systolic excursion (in cm) will be determined by repeat echocardiography after initiation of iNO.
Determining improvement in right ventricular fractional area change in response to iNO
时间窗: Approximately 4 days
Changes in right ventricular fractional area change (in %) will be determined by repeat echocardiography after initiation of iNO.
次要结局
- Improvement in serum creatinine in response to iNO(Approximately 4 days)
- Improvement in urine output in response to iNO(Approximately 4 days)
研究者
Yuri Matusov
Principal Investigator
Cedars-Sinai Medical Center