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

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ClinicalTrials.gov Identifier: NCT04858139
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Lorenz Hirt, MD, Centre Hospitalier Universitaire Vaudois

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Drug: Lactate Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Numbered vials, prepared by hospital pharmacy
Primary Purpose: Treatment
Official Title: "Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo
patients will be injected with placebo
 Drug: Placebo
Intravenous injection (20 min)
Other Name: Saline solution administration
Active Comparator: Lactate
patients will be injected with lactate solution
 Drug: Lactate
Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,


Outcome Measures
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Primary Outcome Measures :
  1. Does the administered lactate reach the brain [ Time Frame: 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.


  2. Does the administered lactate persist in the brain at 24 hours [ Time Frame: 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.


Secondary Outcome Measures :
  1. Effect of lactate on neuronal death after intervention [ Time Frame: Measurement after intervention (as soon as the patient condition allows performing an MRI; estimated between 1 and 2 hours) ]
    Assessment of N-acetyl aspartate (NAA), a neuronal marker, using MRS and compared to baseline values, in the ischemic core and in the ischemic penumbra.

  2. Effect of lactate on neuronal death at 24 hours [ Time Frame: Measurement at during the routine control MRS, approximately 24 hours after EVT ]
    Assessment of N-acetyl aspartate (NAA), a neuronal marker, using MRS and compared to baseline values, in the ischemic core and in the ischemic penumbra.

  3. Effect of lactate on evolution of lesion at 24 hours [ Time Frame: At 24 hours ]
    Assessment of lesion using diffusion weighted Imaging (DWI) compared to baseline value

  4. Effect of lactate on evolution of penumbra at 24 hours [ Time Frame: This evaluation will be based on the routine MRI evaluation performed approximately 24 hours after EVT ]
    Check impact of intervention on the penumbra using perfusion weighted imaging (PWI) at 24 hours compared to baseline

  5. Clinical outcome at 24 hours [ Time Frame: at 24 hours ]
    Evolution of the neurological score (NIHSS) and compared to baseline assessment

  6. Clinical outcome at 3 months [ Time Frame: Measurement at follow up (3 months) ]
    Evolution of neurological score (NIHSS) compared to baseline value

  7. Handicap at 3 months [ Time Frame: Measurement at follow up (3 months) ]
    Evolution of neurological handicap (mRS) compared to baseline value


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858139


Contacts
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Contact: Lorenz Hirt, MD +41213141268 Lorenz.Hirt@chuv.ch
Contact: Patrik Michel, MD +41213141185 Patrik.Michel@chuv.ch

Locations
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Switzerland
CHUVaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Lorenz Hirt, MD    +41213141268    lorenz.hirt@chuv.ch   
Contact: Patrik Hirt, MD    +41213141185    Patrik.Michel@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Lorenz Hirt, MD CHUV
More Information
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Responsible Party: Lorenz Hirt, MD, MD, associate professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04858139    
Other Study ID Numbers: Swissmedic N°2020DR2163
2019-00897 ( Other Identifier: CER-VD )
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will be made available 1 year after the end of the study to other investigators if the patient provides informed consent for further use of his/her data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases