Normothermia in Patients With Acute Cerebral Damage
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Maintenance of normothermia
研究概览
简要总结
The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome in patients with acute cerebral damage admitted to ICU.
详细描述
Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue occurring in 78% of patients with acute cerebral damage admitted to intensive care unit (ICU). For those patients, normothermia is actually recommended in order to reduce secondary cerebral damage and to control intracranial pressure, that are known to worsen long term prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral damage (axillary temperature < 38°C or internal temperature < 38,8°C) administering diclofenac. We will also investigate the corresponding behaviour of intracranial pressure and cerebral perfusion pressure.
Comparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg - 1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for 12 hours.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring
排除标准
- •Know adverse reactions with NSAI
- •Platelets count < 20,000/dl
- •Gastric or duodenal ulceration in active phase
- •Hepatic insufficiency, cirrhosis or previous liver transplant
- •Acute or chronic renal insufficiency
- •Coronary insufficiency, acute myocardial infarct in the previous 6 month
- •Barbiturate coma
- •Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate and cyclosporin.
- •Known or suspected pregnancy
结局指标
主要结局
Maintenance of normothermia
时间窗: within 14 days from ICU admission
次要结局
- Behaviour of intracranial pressure and cerebral perfusion pressure. Influence on six month outcome.(Within 14 days from ICU admission/Six months)