Stroke, AcutePhase 2LacAVCNCT04858139
Exploring the Effect of Lactate Administration After Ischemic Stroke on Brain Metabolism
A Phase 2 study testing Lactate in people with Stroke, Acute, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Aug 2021to 27 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)
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.
Read the 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
- Being tested
- Lactate, Placebo
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactateDrug
Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,
PlaceboDrug
Also called Saline solution administration
Intravenous injection (20 min)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | patients will be injected with placebo Receives: Drug: Placebo |
| Lactate | Active comparator | patients will be injected with lactate solution Receives: Drug: Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: Measurement at during the routine control MRS, approximately 24 hours after EVT
Effect of lactate on evolution of lesion at 24 hours
Assessment of lesion using diffusion weighted Imaging (DWI) compared to baseline value
Measured: At 24 hours
Effect of lactate on evolution of penumbra at 24 hours
Check impact of intervention on the penumbra using perfusion weighted imaging (PWI) at 24 hours compared to baseline
Measured: This evaluation will be based on the routine MRI evaluation performed approximately 24 hours after EVT
Clinical outcome at 24 hours
Evolution of the neurological score (NIHSS) and compared to baseline assessment
Measured: at 24 hours
Clinical outcome at 3 months
Evolution of neurological score (NIHSS) compared to baseline value
Measured: Measurement at follow up (3 months)
Handicap at 3 months
Evolution of neurological handicap (mRS) compared to baseline value
Measured: Measurement at follow up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start5 Aug 2021
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
Why it stopped: Recruitment slow. Standard stroke patient management was changed (CT replacing MRI if NIHSS \> 10). We closed the study to avoid bias (after 28 inclusions /out of 30 planned)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz Hirt, MD, Centre Hospitalier Universitaire Vaudois
- Investigators
- Lorenz Hirt, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858139
- Sponsor's protocol ID
- Swissmedic N°2020DR2163
- Other IDs
- 2019-00897, 2019
- Acronym
- LacAVC
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Exploration de l'Effet Sur le métabolisme cérébral de l'Administration de Lactate après Accident Vasculaire cérébral Chez l'Homme" (French Title)
- ClinicalTrials.gov ID
- NCT04858139
- Acronym / sponsor ID
- LacAVC / Swissmedic N°2020DR2163
- Conditions
- Stroke, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment slow. Standard stroke patient management was changed (CT replacing MRI if NIHSS \> 10). We closed the study to avoid bias (after 28 inclusions /out of 30 planned)
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebopatients will be injected with placebo |
| Lactate | Active comparator | Drug: Lactatepatients will be injected with lactate solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactateIntravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight, | Drug | Lactate |
| PlaceboAlso: Saline solution administrationIntravenous injection (20 min) | Drug | placebo |
Primary outcome
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.
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.
7 secondary outcomes
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)
Effect of lactate on neuronal death at 24 hours
Time frame: Measurement at during the routine control MRS, approximately 24 hours after EVT
Effect of lactate on evolution of lesion at 24 hours
Time frame: At 24 hours
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
Clinical outcome at 24 hours
Time frame: at 24 hours
Clinical outcome at 3 months
Time frame: Measurement at follow up (3 months)
Handicap at 3 months
Time frame: Measurement at follow up (3 months)
Results and safety
The study was stopped early (reason given: Recruitment slow. Standard stroke patient management was changed (CT replacing MRI if NIHSS \> 10). We closed the study to avoid bias (after 28 inclusions /out of 30 planned)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz Hirt, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactate in people with Stroke, Acute, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment slow. Standard stroke patient management was changed (CT replacing MRI if NIHSS \> 10). We closed the study to avoid bias (after 28 inclusions /out of 30 planned)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.