Exploring the Effect of Lactate Administration After Ischemic Stroke on Brain Metabolism

NCT ID: NCT04858139

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2025-03-27

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

patients will be injected with placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous injection (20 min)

Lactate

patients will be injected with lactate solution

Group Type: ACTIVE_COMPARATOR

Lactate

Intervention Type: DRUG

Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,

Interventions

Lactate

Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,

Intervention Type: DRUG

Placebo

Intravenous injection (20 min)

Intervention Type: DRUG

Other Intervention Names

Saline solution administration

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Lorenz Hirt, MD

MD, associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenz Hirt, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

CHUVaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

2019-00897

Identifier Type: OTHER

Identifier Source: secondary_id

Swissmedic N°2020DR2163

Identifier Type: -

Identifier Source: org_study_id