The Effects of Enoximone in Acute Exacerbation COPD
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- PEEP
研究概览
简要总结
Introduction:
The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone.
Methods:
The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.
详细描述
Ventilator will be set during the study period at Volume Controle, 6 ml/kg, 5 PEEP and a respiratory rate of 15 bpm with an I:E-ratio of 1:2.
Salbutamol/ipratropium bromide and magnesium sulphate will be administered at baseline (t=0h) and measurements will be made for an hour.
At T=1h the first dose of 0.5 mg/kg enoximone will be administered and will be repeated at T=2h and T=3h. Ventilator derived variables will be obtained every fifteen minutes and echocardiography, arterial and central venous bloodgas analyses every hour until t=6h.
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
- •Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.
排除标准
- •Patients with known asthma or interstitial lung disease (ILD)
- •Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia
- •Hypertrophic obstructive cardiomyopathy (HOCM)
- •Severe aortic stenosis with aortic valve area < 1cm2
- •Known ventricular arrhythmias
- •Severe kidney disorders with Glomerular Filtration Rate (GFR) < 30
- •Severe liver insufficiency with spontaneous PT/INR > 1.5
- •Pregnancy
- •Lactation
- •High dose-diuretics use (daily dose of >480 mg furosemide)
研究组 & 干预措施
Enoximone
Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.
干预措施: Enoximone (Drug)
结局指标
主要结局
PEEP
时间窗: within 6 hoursmeasured every 15 minutes
Reduction in intrinsic PEEP, in cmH2O
次要结局
- Airway resistence(within 6 hours, measured every hour)
- VCO2(within 6 hours, measured every hour)
- etCO2(within 6 hours, measured every hour)
- FiO2(within 6 hours, measured every hour)
- Vd/Vt(within 6 hours, measured every hour)
- Lung compliance(within 6 hours, measured every hour)
- VEI(within 6 hours, measured every hour)
- Shunt fraction(within 6 hours, measured every hour)
- Cardiac Output(within 6 hours, measured every hour)
- RVSP(within 6 hours, measured every hour)
- TAPSE(within 6 hours, measured every hour)
- MAPSE(within 6 hours, measured every hour)
- LV Ejection Fraction(within 6 hours, measured every hour)
- Bloodgas analysis(within 6 hours, measured every hour)