A Randomized, Exploratory, Open-label, Phase IV, Blinded Endpoint, Multicenter and Prospective Study to Evaluate the Effect of the Addition of Esmolol on the Current Therapeutic Regimen Used for the Treatment of Hemorrhagic Stroke
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- To evaluate comparatively the drug test and the comparator drug
研究概览
简要总结
Because of its pharmacokinetic characteristics, such as short half-life and its safety profile, esmolol hydrochloride is a beta blocker suitable for venous use in the form of continuous infusion. Strategies that improve the blood pressure control of patients with hemorrhagic stroke during the first hours of hospitalization are determinant in controlling the hematoma expansion and determining factor in its prognosis. This study was designed with the objective of evaluating the beneficial effects of combining esmolol hydrochloride with sodium nitroprusside for the blood pressure control of participants with hemorrhagic stroke.
详细描述
Participants with parenchymal intracranial hemorrhage (diagnosis confirmed by computed tomography or magnetic resonance imaging), and:
- with systolic pressure > 150 mmHg,
- not contraindicated for treatment with beta-blockers,
- who can start the drug treatment within 6 hours of the stroke,
- having a target of ≤ 140 mmHg of systolic pressure within 1 hour after initiation of treatment.
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
- 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
- •Signature of the TCLE by participant or companion.
- •Spontaneous intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and fit to be included in the study and initiate therapy with study medications within 6 hours after the event.
- •Intracerebral hemorrhage (volume < 30 cm3).
- •No immediate surgical indication.
- •Both sexes, aged above 18 years.
- •Systolic blood pressure (> 150 mmHg and < 220 mmHg) measured on two occasions with a minimum difference of 2 minutes.
排除标准
- •Cerebral hemorrhage secondary to structural lesions in the brain, vascular malformations, coagulopathies or traumatic brain injury, if known at the time of randomization.
- •Participant in deep coma, defined by the Glasgow Coma Scale score of 3 to
- •Uncontrolled asthmatic or COPD participants, if known at the time of randomization.
- •Participants with Grade IV Heart Failure, defined as heart rate < 50 beats per minute.
- •Previous hemorrhagic stroke, if known at the time of randomization
- •Participants with Cerebral Vascular Stroke.
- •Participants who have presented previous ischemic cerebrovascular accident, if known at the time of randomization.
- •Chronic diseases with life expectancy less than 3 months.
- •Score ≥ 4 on the ICH score at the time of recruitment.
- •In use of anticoagulants in the last 48 hours, if known at the time of randomization.
- •Patients with contraindication to any of the study medications.
- •Intubation Orotraqueal on arrival at the service.
- •Pheochromocytoma, if known at the time of randomization.
- •Patients with hyperthyroidism, if known at the time of randomization.
- •Known pregnancy or breastfeeding . At the discretion of the investigator, an examination for confirmation may be requested.
研究组 & 干预措施
Brevibloc, 10 Mg/mL Intravenous Solution
10 mL/h every 5 minutes until reaching the pressure target
干预措施: Brevibloc, 10 Mg/mL Intravenous Solution (Drug)
Brevibloc, 10 Mg/mL Intravenous Solution
10 mL/h every 5 minutes until reaching the pressure target
干预措施: Nitroprusside, Sodium (Drug)
Nitroprusside, Sodium
0.5 mcg / kg / min every 3 minutes until reaching the pressure target
干预措施: Nitroprusside, Sodium (Drug)
结局指标
主要结局
To evaluate comparatively the drug test and the comparator drug
时间窗: 7 days
Variation of systolic and diastolic pressure during the time of use of the investigational products measured by ABPM (outpatient blood pressure monitoring).
次要结局
- To compare the percentage of participants(in the first hour of treatment between the groups.)
- Rankin Scale(in 90 ± 4 days)
- MOCA scale(in 90 ± 4 days)
- Severe hypotensive events with clinical consequences(in 90 ± 4 days)
- Adverse events related with investigational product(in 90 ± 4 days)
- Severe cardiovascular events(in 90 ± 4 days)
- Frequency of changes in baseline cardiac troponin levels(24 ± 4 and 72 ± 4 hours)
- NIH Stroke Scale (NIHSS) and Glasgow Coma Scale(from admission to discharge or 7th day)
- Hematoma volume expansion and perihematoma volume of cerebral edema(24 ± 4 hours)
- Frequency of changes in the ECO(in the first 72 ± 4 hours and the return after 90 ± 3 days)
- Bradycardia(in 90 ± 4 days)
- QT interval variability(during the infusion period)
- Frequency of changes in the level of BNP(at baseline times, 24 ± 4 and 72 ± 4 hours)
- Frequency of intra-cranial hypertension(7 days)