NCT04858139

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

"Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lactate	Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,
DRUG	Placebo	Intravenous injection (20 min)

Timeline

• Start date: 2021-08-05
• Primary completion: 2025-03-27
• Completion: 2025-03-27
• First posted: 2021-04-26
• Last updated: 2025-04-17

Locations

1 site across 1 country: Switzerland