Acute Effect of Recombinant Human Brain Natriuretic Peptide in Patients With Pulmonary Hypertension Associated With Acute Exacerbation of Chronic Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter
研究概览
简要总结
To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by Swan- Ganz catheter.
详细描述
Pulmonary hypertension (PH) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients. Currently, no effective drugs treatment was used in patients with pulmonary hypertension due to acute exacerbation of lung disease. Recombinant Human Brain Natriuretic Peptide (rhBNP)was approved in 2001 for use in patients with acute heart failure on the basis of studies showing a reduction in pulmonary-capillary wedge pressure(PCWP) and pulmonary arterial pressure (PAP) and improvement cardiac output (CO) . Thus, the study was designed to administer rhBNP as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by Swan- Ganz catheter. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 years old, male or female;
- •in acute exacerbation period and with a history of chronic respiratory diseases;
- •cardiac ultrasound showed a pulmonary hypertension ≥50mmHg;
- •grade II or WHO grade of heart function;
- •signed informed consent.
排除标准
- •pulmonary hypertension not associated with chronic lung disease;
- •Acute or severe chronic left heart failure;
- •severe respiratory failure during receipt of non-invasive or invasive ventilator therapy;
- •mPAP≤25mmHg or pulmonary capillary wedge pressure (PCWP) ≥15mmHg at rest as assessed by Swan- Ganz catheter;
- •a high risk of hypotension (systolic pressure <100 mmHg or 110 mmHg with the use of intravenous nitroglycerin);
- •Uncontrolled arterial hypertension;
- •acute coronary syndrome;
- •Severe left ventricular hypertrophy;
- •Congenital or acquired valvular or myocardial disease;
- •end-stage renal disease during receipt of renal replacement therapy;
- •clinically significant anemia;
- •other contraindications for vasodilators;
- •treatment with dobutamine (at a dose ≥5 μg per kilogram of body weight per minute);
- •treatment with milrinone or levosimendan within the previous 30 days.
研究组 & 干预措施
rhBNP
the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received rhBNP.
干预措施: rhBNP (Drug)
Placebo
the study is a self controlled study. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.The date of this arm is from the occasion the subject received placebo.
干预措施: placebo (Drug)
结局指标
主要结局
pulmonary artery diastolic pressure(PADP) measured by Swan-Ganz catheter
时间窗: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
pulmonary vascular resistance(PVR) measured by Swan-Ganz catheter
时间窗: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
pulmonary artery systolic pressure (PASP) measured by Swan-Ganz catheter
时间窗: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
cardiac output(CO) measured by Swan-Ganz catheter
时间窗: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
mean pulmonary artery pressure(mPAP) measured by Swan-Ganz catheter
时间窗: baseline , 0.5 hour, 1hour, 2hours, 4hours, 8hours, 12hours, 20hours, 24hours, 27hours and 30hours
we are going to record a change
次要结局
- oxygenation index in artery blood gas analysis(baseline and 30 hours)
- heat rate (HR)(baseline and 30 hours)
- blood pressure(BP)(baseline and 30 hours)
- alveolar-arterial oxygen difference in artery blood gas analysis(baseline and 30 hours)
- respiratory rate(RR)(baseline and 30 hours)
- Potential of Hydrogen(PH) in artery blood gas analysis(baseline and 30 hours)
- blood oxygen saturation(SPO2)(baseline and 30 hours)
- arterial partial pressure of carbon dioxide (PaCO2)(baseline and 30 hours)
- arterial partial pressure of oxygen(PaO2)(baseline and 30 hours)
- Brog classification(baseline and 30 hours)
- Brain Natriuretic Peptide(BNP) in blood(baseline and 30 hours)
- N-terminal pro-Brain Natriuretic Peptide(NT-pro BNP) in blood(baseline and 30 hours)
研究者
LI ZHAO
professor /director
Shengjing Hospital