NCT03761888Unknown不适用
How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.
研究概览
简要总结
Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged up to 18 years
- •patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain.
- •Decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine
排除标准
- •history of intracranial expansive processus, surgery or vascular disease
- •infectious state on probe placement
- •unilateral anophthalmia
结局指标
主要结局
Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.
时间窗: just before treatment and 2 hours after
Variation of values will be studied during a 2 hour time period, starting just before administration of either labetalol or nicardipine by i.v. route
次要结局
- proportion of optic nerve sheath up to 5.8 mm in each group(just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours)
- variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route(just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours)
- variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route(just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours)
- proportion of pathologic PI in middle cerebral artery in each group(just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours)
- values of optic nerve sheath diameter in each group(At 30 minutes to 60 minutes and 6 hours to 8 hours)
研究者
Dr Mickaël Soued
Principal Investigator
Hopital Antoine Beclere
研究点 (1)
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