Quelling of Excitotoxicity in Acute Stroke With Ketamine
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.
研究概览
简要总结
The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.
详细描述
After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. The infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 1 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time
- •An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate
- •Pre-stroke modified Rankin scale of 0-2
- •Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.
排除标准
- •Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy
- •Longer than 24 hours since last known well time
- •Pre-stroke modified Rankin scale of 3 or above.
- •Pregnant or lactating females
- •Pre-existing psychiatric illness
- •Intracranial hemorrhage of any type at presentation
- •Seizure at onset of symptoms
- •Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications
- •Known hypersensitivity or adverse reaction to prior administration of Ketamine
- •Inability/refusal to provide consent by the patient or through a proxy
研究组 & 干预措施
Study Drug
Will receive Ketamine infusion, and Midazolam (Versed).
干预措施: Ketamine (Drug)
Study Drug
Will receive Ketamine infusion, and Midazolam (Versed).
干预措施: Midazolam injection (Drug)
Placebo
Will receive Normal saline infusion and Midazolam (Versed).
干预措施: Normal Saline (Other)
Placebo
Will receive Normal saline infusion and Midazolam (Versed).
干预措施: Midazolam injection (Drug)
结局指标
主要结局
Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.
时间窗: On day 1 and at 90 days
An improvement of 2 in mRS score will be considered favorable outcome.
次要结局
- Barthel's index(On day 1, and at 90 days)
- Infarct volumes(On day 1, and day 4 or discharge whichever is earlier)
- Symptomatic intracranial hemorrhage(Day 4 or discharge whichever is earlier)
- NIH stroke scale score(On day 1, day 4 or discharge whichever is earlier, and at 90 days)
- Depression score using the PHQ9 questionnaire(On day 1, and day 4 or discharge whichever is earlier.)
- All cause mortality(90 days)
- Stroke-related mortality(90 days)
- Deterioration in neurologic status(Up to day 4 or discharge whichever is earlier)
研究者
Sudhir Aggarwal MD, PhD,
Neurologist and Medical Director
Lower Merion Neurology Research Foundation