Systemic Normothermia in Intracerebral Hemorrhage (ICH)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- MRI measurement of relative perihematomal edema (% change of perihematomal edema)
研究概览
简要总结
Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.
详细描述
This is a randomized device efficacy trial. Patients with a supratentorial intracerebral hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of symptom onset and who have not experienced episodes of temperature elevation will be enrolled after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads applied to the torso and thighs for five days. The Arctic Sun device will keep the body temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the active comparator arm will receive a standard of care treatment at the discretion of the treating physician. Patients will have hourly measurement of blood pressure, heart rate, respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS), telemetry monitoring and labs will also be performed daily. The investigators will also collect demographic information about the patients (i.e. age, gender, medical risk factors) and information regarding their current disease process.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with spontaneous supratentorial ICH >20 cc
- •Age 18 to 85 years of age
- •Consent from the patient or surrogate decision maker
- •Within 24 hours of onset of ictus
排除标准
- •Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
- •Moribund state and deemed unlikely to survive until study completion (5 days)
- •Patients with a don-not-resuscitate (DNR) order
- •Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
- •Evidence of a blood dyscrasia
- •Renal failure (CCR < 50 ml/min)
- •Contraindications for a brain MRI scan
- •Infratentorial ICH
- •Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours
- •Episode of fever > 38.5 degrees Celsius prior to enrollment
结局指标
主要结局
MRI measurement of relative perihematomal edema (% change of perihematomal edema)
时间窗: First 5 days of hospital course
Percent relative perihematomal edema growth between the initial MRI and the 5 day MRI
次要结局
- Structured telephone interview of functional and cognitive outcome(3 months and 1 year)
- Serum cytokine measurement with inflammatory cytokine protein array(5 days)