"Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Does the administered lactate reach the brain
研究概览
简要总结
In this exploratory randomized double blind placebo controled trial, lactate solution or placebo will be administered to acute ischemic stroke patients selected for endovascular treatment (EVT) without intravenous thrombolysis. The treatment will be administered within one hour after EVT. Primary outcome measures will be lactate and metabolite concentrations in the ischemic lesion, in the penumbra and contralaterally, evaluated by magnetic resonance spectroscopy(MRS). Secondary outcome measures will be evolution of the ischemic penumbra, clinical outcome at 3 months.The trial will end when 10 patients per group have completed the study.
详细描述
This is an exploratory randomized double blind placebo controled trial on acute ischemic stroke patients. Lactate solution or placebo will be administered to acute ischemic stroke patients selected for endovascular treatment (EVT) without intravenous thrombolysis. Magnetic resonance spectroscopy will be performed before EVT to measure metabolite concentrations in the ischemic core, penumbra and in the contralateral hemisphere. The treatment will be administered within one hour after EVT. As soon as the patient is stabilized, she/he will undergo an additional magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS). MRS will also be performed during the control MRI after 24 hours. Neurological deficits will be evaluated on admission, at 24 hours using the National Institute of Health Stroke Scale (NIHSS), and at 3 months, with both NIHSS and the modified Rankin scale. Primary outcome measures will be lactate and metabolite concentrations changes in the ischemic lesion, in the penumbra and the contralateral side, evaluated by magnetic resonance spectroscopy after intervention compared to baseline MRS values. Secondary outcome measures will be evolution of the ischemic penumbra and clinical outcome at 3 months. The trial will end when 10 patients per group have completed the study.
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)
盲法说明
Numbered vials, prepared by hospital pharmacy
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
- •Acute ischemic stroke with arterial occlusion affecting middle cerebral artery (segment M1or segment 2) or internal carotid artery (T-type or L-type occlusion) selected for EVT
- •not eligible for intravenous thrombolysis (IVT)
- •Moderate to severe stroke (NIHSS > or = 4), and preadmission mRS > or = 3)
- •Perfusion - diffusion mismatch
- •Obtain consent from independent Doctor Randomisation criteria
- •If possible oral consent from patient or relatives
- •Treatment administration possible within 1h from EVT
排除标准
- •Rapid neurological recovery
- •Clinically unstable patient
- •Contraindications to MRI
- •Blood Na+ > 155 mmol/l or plasma osmolality > 320 mosmol/l
- •Medical history of traumatic brain injury (TBI), neurodegenerative disease, intracranial hemorrhage, cerebral aneurysm, brain tumour
- •Medical history of psychiatric disorders
- •Liver insufficiency
- •Heart failure
- •Pregnancy (pregnancy test required in women aged under 50 unless patient or relatives indicate that the patient is not pregnant)
- •Participation in another clinical trial in the last 30 days
- •Lack of consent of an independent Doctor
研究组 & 干预措施
placebo
patients will be injected with placebo
干预措施: Placebo (Drug)
Lactate
patients will be injected with lactate solution
干预措施: Lactate (Drug)
结局指标
主要结局
Does the administered lactate reach the brain
时间窗: Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours)
Measurement of lactate and other metabolites in lesion, penumbra, contralateral side using magnetic resonance spectroscopy measured after intervention and compared to baseline values. After intervention, the MRS will be performed as soon as possible considering that these patients have an EVT under general anesthesia and need to be stabilised after the EVT and study treatment intervention before the MRS.
Does the administered lactate persist in the brain at 24 hours
时间窗: The MRS will be performed during the routine clinical MRI approximately 24 hours after EVT
Measurement of lactate and other metabolites in lesion, penumbra, contralateral side using magnetic resonance spectroscopy measured at 24 hours and compared to baseline values.
次要结局
- Effect of lactate on neuronal death after intervention(Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours))
- Effect of lactate on neuronal death at 24 hours(Measurement at during the routine control MRS, approximately 24 hours after EVT)
- Effect of lactate on evolution of lesion at 24 hours(At 24 hours)
- Clinical outcome at 3 months(Measurement at follow up (3 months))
- Handicap at 3 months(Measurement at follow up (3 months))
- Effect of lactate on evolution of penumbra at 24 hours(This evaluation will be based on the routine MRI evaluation performed approximately 24 hours after EVT)
- Clinical outcome at 24 hours(at 24 hours)
研究者
Lorenz Hirt, MD
MD, associate professor
Centre Hospitalier Universitaire Vaudois