Efficacy and Safety of Prazosin in Gullian barre syndrome with Sympathetic over-activity : an open level Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time (days) to achieve resolution of sympathetic overactivity.
研究概览
简要总结
Autonomic dysfunction is observed in around 60% of patients with GBS, potentially leading to fatal cardiovascular outcomes such as cardiac arrest, arrhythmias, cardiomyopathy, and PRES. Mortality rates can range from 6-13%. Studies show both sympathetic and parasympathetic systems can be affected, resulting in manifestations such as sinus tachycardia, bradycardia, and fluctuations in blood pressure. Sympathetic overactivity, often due to catecholamine excess, is a common feature of GBS-related dysautonomia. Prazosin, an alpha1 receptor blocker, has shown promise in alleviating sympathetic overdrive by reducing preload and left ventricular impedance without causing significant tachycardia. A recent study by Kumar et al. demonstrated improved heart rate variability and blood pressure control with prazosin treatment in GBS patients. This trial aims to determine the efficacy of prazosin in managing dysautonomia in GBS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria: Patients with GBS, diagnosed according to the clinical, CSF and electro-diagnostic criteria, having signs or symptoms of sympathetic over-activity based on predefined criteria will be included in this study.
- •Diagnostic criteria for sympathetic over-activity (SO) Sympathetic overactivity (SO) was considered when any of the following four features will be present for two consecutive days: (1) sustained hypertension defined as systolic BP ≥ 150mm of Hg and/or diastolic BP ≥100mm of Hg; or (2) persistent tachycardia as daily mean HR of ≥ 125 bpm (Transient tachycardia and bradycardia were not considered as a part of autonomic dysfunction); (3) or labile BP defined as daily sustained SBP deviation ≥ 40mm of Hg or DBP fluctuations ≥ 20mm of Hg, (4) or labile HR defined as daily pulse changes by ≥ 50 bpm; and, (5) along with exclusion of secondary causes such as sepsis, cardiogenic, mechanical ventilation related complications such as hypoxia or hypercapnia, pulmonary thromboembolism and hypovolemia.
排除标准
- •1.Guillain-Barre variants such as Miller-Fisher syndrome (MFS), pure sensory GBS, pharyngeal cervical brachial (PCB) variant, and facial diplegia with limb paresthesia or ataxic GBS syndromes .
- •Patients with pre-existing diabetes mellitus (DM), hypertension, coronary artery disease (CAD), , any chronic illness such as cardiac, hepatic and renal diseases .
- •already on betablocker for other clinical conditions
- •those with missing data will also be excluded.
- •Patients with hypotension ( systolic BP of less than 90mm of Hg or need for vasoactive agents, and/or bradycardia (defined as resting HR of less than 50 bpm) at admission.[ if bradycardia or hypotension occur after initiation of prazosin will not be excluded.].
结局指标
主要结局
Time (days) to achieve resolution of sympathetic overactivity.
时间窗: 15 days
次要结局
- Mean fluctuation of diastolic BP at 15 days
研究者
Mritunjai Kumar
AIIMS Rishikesh