Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Control of Hypertensive Crisis
研究概览
简要总结
Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 24 weeks.
- •Hypertensive Crisis (systolic pressure > 160 mmHg / diastolic pressure < 110mmHg).
排除标准
- •Known allergy to hydralazine.
- •Known allergy to labetalol.
- •Severe Bradycardia
研究组 & 干预措施
Hydralazine
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
干预措施: Hydralazine (Drug)
Labetalol
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).
干预措施: Labetalol (Drug)
结局指标
主要结局
Control of Hypertensive Crisis
时间窗: 10 months
Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.
次要结局
- Adverse reactions(10 months)
- Number of doses(10 months)
研究者
Osvaldo A. Reyes T.
Coordinator of Research and Development
Saint Thomas Hospital, Panama