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

NCT04858139 | Terminated Phase 2 DMC

• 2 other identifiers: Swissmedic N°2020DR21632019-00897
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (2)

• Does the administered lactate reach the brain

  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.

  Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours)

• Does the administered lactate persist in the brain at 24 hours

  Measurement of lactate and other metabolites in lesion, penumbra, contralateral side using magnetic resonance spectroscopy measured at 24 hours and compared to baseline values.

  The MRS will be performed during the routine clinical MRI approximately 24 hours after EVT

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

placebo

PLACEBO COMPARATOR

patients will be injected with placebo

Drug: Placebo

Lactate

ACTIVE COMPARATOR

patients will be injected with lactate solution

Drug: Lactate

Interventions

Lactate DRUG

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

Lactate

Placebo DRUG

Intravenous injection (20 min)

Also known as: Saline solution administration

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

CHUVaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Stroke

Interventions

Lactic Acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Lorenz Hirt, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Numbered vials, prepared by hospital pharmacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, associate professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 26, 2021
• Study Start: August 5, 2021
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)