The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Blood pressure at two hours
研究概览
简要总结
The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.
- efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
- safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).
Pharmacokinetic study included to study :
- transplacental transfer,
- transfer in breast milk,
- and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Singleton pregnancy
- •Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated
- •Patient with PE, as defined by :
- •Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
- •Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,
- •Patient with severe Pregnancy Induced Hypertension (PIH), as defined by :
- •Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,
- •Written informed consent signed and dated by both investigator and patient,
- •Valid social security affiliation
排除标准
- •Known allergy to study drugs
- •Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days.
- •Eclampsia
- •Person with difficulty understanding information
- •Person with diminished responsibility,
- •Ongoing intravenous antihypertensive treatment,
- •No pressure cuff adapted to the morphology of the arms of the patients
- •Concomitant use of 5 phosphodiesterase inhibitors
- •Participation in a clinical trial within 6 months prior to inclusion
研究组 & 干预措施
Urapidil
Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.
The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.
Maximum dose of 30 mg.h-1.
干预措施: Urapidil (Drug)
Nicardipine
Nicardipine : IV
1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.
Maximum dose of 6 mg.h-1
干预措施: Nicardipine (Drug)
结局指标
主要结局
Blood pressure at two hours
时间窗: up to 4 days
次要结局
未报告次要终点