Efficacy of corticosteroid therapy on neurological outcomes in near-hanging patients with altered sensorium: A multi-centre, double-blinded, placebo-controlled, randomized trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- The primary outcome is to assess the neurological outcome in near hanging patients with altered sensorium after treating them with corticosteroid or placebo.
研究概览
简要总结
Hanging is the most common method of suicide in India, accounting for 58.2% of all suicides. In hanging attempt, Due to the pressure on the major vessels and airway, hypoxic-ischemic damage and cerebral edema occur in the brain. Corticosteroids are widely used to reduce cerebral edema. However, evidence for the utility of steroids for this indication is lagging, and it is not proven in randomized controlled trials.
Near hanging patients with altered sensorium (Glasgow Coma Scale of 13 or less) will be recruited in this study. In addition to standard medical care, participants will undergo randomization to receive either steroid therapy or a placebo for cerebral edema. The neurological status at the time of discharge and day 28 will be assessed using the Glasgow Outcome Scale, whether good or poor. We will also compare the length of hospital stay between the two groups and document any in-hospital complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Near-hanging adult patients aged 18 years or more Presented with altered sensorium, having a GCS score of 13 or less Presented within 48 hours of the hanging attempt.
排除标准
- •Patients tried other methods of suicide concurrently Treatment for more than 24 hours with 20 mg of dexamethasone or an equivalent dose of corticosteroids before enrolment.
- •Active tuberculosis, HIV infection, recent steroid use or other immunosuppressant therapy Definite indication or contra-indication to steroid therapy Allergies to the study drug Pregnancy or breastfeeding Patients having underlying neurological diseases Hanging induced cervical spine injury Moribund patients Informed consent not given.
结局指标
主要结局
The primary outcome is to assess the neurological outcome in near hanging patients with altered sensorium after treating them with corticosteroid or placebo.
时间窗: day 28
The Glasgow outcome scale is used to assess neurological outcomes whether it is good or poor.
时间窗: day 28
Good outcomes include Complete recovery and Disabled but independent
时间窗: day 28
Poor outcomes include Death, Persistent vegetative state and Dependent on daily life activities
时间窗: day 28
次要结局
- The neurological outcome using Glasgow outcome scale(at the time of discharge)
- length of hospital stay(at the time of discharge)
- in-hospital complications(during hospitalization)
研究者
Ramadoss R
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)