High Versus Low Dose Nitroglycerin in Management of Sympathetic Crashing Acute Pulmonary Edema
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resolution of symptoms
研究概览
简要总结
The goal of this randomized controlled trial is evaluate the out come of:
- Low dose (< 100 mic/min )versus
- High dose (> 100 mic/min) of nitroglycerin in management of patients with acute pulmonary edema presented to Emergency Department of Alexandria University Hospitals.
The main questions it aims to answer is:
- Time of resolution of high blood pressure, hypoxia, tacchypnea
- Need for invasive mechanical ventilation, ICU admission
详细描述
This single blind parallel randomized controlled trial will be conducted on (30 patients in each group) presented to Alexandria University Hospitals with acute pulmonary edema defined as: acute onset of dyspnea < 6 hrs, tacchypnea ( respiratory rate ≥30 breaths/min), bilaterak crepitations, O2 saturation < 90% on room air with associted sympathetic surge recognized by presence of tacchycardia, agitationa and blood pressure ≥ 160/90 mmHg
All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
- Group (A): Low dose group Nitroglycerin at will be initiated at a rate <100 mic/min (15)
- Group (B): high dose group Initial dose > 100 mic /min (15) will be started Blood pressure will be measured for both groups every 15 minutes and dose adjusted accordingly, if the blood pressure starts to decrease continue infusion rate. In case of rising or constant blood pressure increase nitroglycerin by 20 mic/min every 15 min till blood pressure starts to decrease.
Initial, peak rate within the first hour, duration of IV nitroglycerin infusion will be recorded in both groups.
Initial and maximum dose of loop diuretic will be recorded in both groups.
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
- Single (Participant)
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
- •All adult patients (> 18 years) presented with sympathetic crashing acute pulmonary edema.
排除标准
- •1 - Patients indicated for emergency endotracheal intubation. 2-Patients with history of nitroglycerin allergy. 3-Preload dependent patients as patients with aortic stenosis. 4-Drug interaction with nitroglycerin as sildenafil, ergots. 5-Patients indicated for emergency percutaneous intervention.
研究组 & 干预措施
High dose Nitroglycerin
Initial dose of >100 mic/min will be initiated
干预措施: Nitroglycerin (Drug)
Low dose Nitroglycerin
Initial dose < 100 mic /min will be started
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Resolution of symptoms
时间窗: approximately 6 months
( hypoxia, high blood pressure and tacchypnea )
次要结局
未报告次要终点