Mild Hypothermia in Acute Ischemic Stroke
關鍵詞
抽象
描述
Fever is associated with higher stroke mortality and poor outcome, but it is yet unknown whether this association is causative or epiphenomenal.
In temporary brain ischemia rodent models hypothermia results in a significant increase in the number of surviving neurons and smaller infarction size as measured with histological examination after death.
Therapeutic effect has been shown in clinical trials in comatose cardiac arrest patients and newborn infants with perinatal hypoxic-ischemic brain injury.
Design: A prospective, open, randomized single-center study.
Study population: 36 patients, 18-85 years of age presenting with symptoms of acute ischemic hemispheric stroke with persisting significant neurological deficit (NIHSS 7-20 or NIHSS 2 for dysphasia or NIHSS 3 for paralysis of upper or lower limb) at 2 hours after thrombolysis.
Method: Patients are randomized to hypothermia- or control-group via randomization envelopes. Patients assigned to receive hypothermia are cooled to a core temperature of 35°C for 12 hours by means of a non-invasive temperature management system and cold i.v. fluids. Induction of hypothermia is initiated within 6 hours of symptom onset. After 12 hours of successful cooling the target temperature is gradually raised to achieve slow re-warming of 0.2°C/h until the core temperature reaches 36.8°C.
Patients are breathing spontaneously and shivering is controlled with following medication; dexmedetomidine 0.2-0.7 µg/kg/h (i.v.), buspirone 5-20 mg x 3 (nasogastric tube), and meperidine 25mg (i.v.) when needed.
Core temperature, blood pressure (BP), oxygen saturation, ECG and EEG are measured continuously and registered hourly. Blood tests will be taken before, during and after hypothermia. Brain CT will be controlled when normothermia is reached, no later than 30 hours from symptom onset. Brain MRI will be performed 3-7 days from symptom onset.
日期
| 最後驗證: | 08/31/2011 |
| 首次提交: | 09/29/2009 |
| 提交的預估入學人數: | 09/29/2009 |
| 首次發布: | 09/30/2009 |
| 上次提交的更新: | 09/16/2011 |
| 最近更新發布: | 09/19/2011 |
| 實際學習開始日期: | 06/30/2007 |
| 預計主要完成日期: | 08/31/2011 |
| 預計完成日期: | 08/31/2011 |
狀況或疾病
干預/治療
Device: Hypothermia
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Hypothermia | Device: Hypothermia Hypothermia to core temperature of 35C for 12 hours, rewarming rate 0.2C until the patient reaches 36.8C |
| No Intervention: Control |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: - Acute ischemic hemispheric stroke treated with Actilyse(tPA)-thrombolysis according to Meilahti protocol - NIHSS 7-20 (after thrombolysis) or a significant paresis of arm or leg (NIHSS 3, no movement against gravity) or a significant dysphasia (NIHSS 2-3) despite of the total NIHSS score - Symptom onset within 6 hour Exclusion Criteria: - Platelet count < 75,000/mm3 - Known coagulopathy (INR spontaneously >1.5) - Hemodynamical unstability - Recent history of angina pectoris or acute myocardial infarction - Sepsis within 72 hours - Pregnancy - Pre-existing neurological disability with modified Rankin Scale Score>2 - Known allergy or intolerance to buspirone, dexmedetomidine, meperidine - Intracranial hemorrhage in brain CT scan - Intracranial mass lesion (i.e., abscess, tumor, or infection) - Participation in an other therapy trial within last 3 months - Hypothermia- treatment cannot be initiated within 6 hours of symptom onset - Protocol violation in thrombolytic therapy - Any condition where researchers assume that the patient is not suitable (must be reasoned) |
結果
主要結果指標
1. The proportion of patients maintaining temperature below 36.0°C 80% of the 12-hour hypothermia period. [12 hours]
次要成果指標
1. The incidence of intracerebral hemorrhage, infections, hemodynamically significant cardiac arrhythmias, severe disturbance of electrolytes and fluid balance, thrombocytopenia, and serious adverse events [14 days]
2. All-cause mortality during acute phase (7 days), 1 month, and 3 month follow-up; and readmission to hospital for any reason within 3-months. [3 months]
3. The proportion of modified Rankin Scale-responders (mRS 0-2), Barthel Index, NIHSS, Glasgow Outcome Scale [3 months]
4. Neuropsychological tests [3 months]
5. Size of infarction in MRI, and grading of the possible hemorrhagic transformation according to SITS scale (MRI includes scout images, DWI, T1, T2, FLAIR, T2*, and MR angiography) [3-7 days]
