Randomized Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Number of Participants With Normal Right Ventricular (RV) Function and Viability
研究概览
简要总结
This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled nitric oxide or placebo (oxygen).
详细描述
This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction. Investigators hypothesize that the administration of inhaled NO + oxygen to patients with severe submassive PE will improve RV function, reduce RV strain and necrosis and improve dyspnea (difficulty breathing) more than sham oxygen treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age >/= 18
- •Pulmonary imaging-proven PE, as interpreted by local radiologist
- •At least one predictor of RV dysfunction:
- •echocardiography with RV dilation or hypokinesis,
- •estimated RVSP >40mm HG,
- •RV>LV on CTPA,
- •elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),
- •screening bedside cardiac ultrasound with color flow capability that shows RV dysfunction,
- •RV strain on ECG
- •Plan to admit to a bed with telemetry capability
排除标准
- •Vasopressor support at time of enrollment
- •Pregnancy
- •Plan by clinical care team to use lytic or surgical embolectomy
- •Plan by clinical team to use platelet inhibiting drugs
- •Contraindication to anticoagulation
- •Altered mental status such that the patient is unable to provide informed consent
- •Inability to use a nasal cannula or face mask
- •Comfort care measures instituted
- •Supplemental oxygen requirements greater than can be administered via nasal cannula in order to maintain Sa)2 > 80%
- •Pneumothorax with decompression
- •Serum MetHb > 10%
- •Recent use of drugs known to increase cGMP
- •Use of nitroprusside or nitroglycerin within the last 4 hours
- •Use of any other nitrates with in the past 24 hours
- •Use of a fibrinolytic medicine within the past 14 days
研究组 & 干预措施
Inhaled Nitric Oxide
Inhaled nitric oxide
干预措施: Inhaled Nitric Oxide (Drug)
Placebo
Oxygen
干预措施: Sham (Drug)
结局指标
主要结局
Number of Participants With Normal Right Ventricular (RV) Function and Viability
时间窗: 5 days or hospital discharge (whichever occurs first)
Right ventricular (RV) function and viability assessed by the composite of normal RV size (\<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) \> 16 mm and normal right ventricular index of myocardial performance (RIMP) \< 0.40 using spectral Doppler or \< 0.55 using tissue Doppler) and normal fractional area change (FAC) (\> 33%) and a serum hsTnT \< 14pg/mL. Missing values will be considered normal.
次要结局
未报告次要终点
研究者
Jeffrey Kline
Vice Chair of Research
Indiana University School of Medicine