Clinical trial NCT04858139: Exploring the Effect of Lactate Administration After Ischemic Stroke on Brain Metabolism
Official title: "Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke, Acute
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Does the administered lactate reach the brain
timeFrame: Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours)
measure: Does the administered lactate persist in the brain at 24 hours
timeFrame: The MRS will be performed during the routine clinical MRI approximately 24 hours after EVT
Secondary outcomes:
measure: Effect of lactate on neuronal death after intervention
timeFrame: Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours)
measure: Effect of lactate on neuronal death at 24 hours
timeFrame: Measurement at during the routine control MRS, approximately 24 hours after EVT
measure: Effect of lactate on evolution of lesion at 24 hours
timeFrame: At 24 hours
measure: Effect of lactate on evolution of penumbra at 24 hours
timeFrame: This evaluation will be based on the routine MRI evaluation performed approximately 24 hours after EVT
measure: Clinical outcome at 24 hours
timeFrame: at 24 hours
measure: Clinical outcome at 3 months
timeFrame: Measurement at follow up (3 months)
measure: Handicap at 3 months
timeFrame: Measurement at follow up (3 months)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUVaudois
state: Vaud
Study officials:
affiliation: CHUV
name: Lorenz Hirt, MD
role: PRINCIPAL_INVESTIGATOR
References: