Cardiac ArrestPhase 2LATTENCT05004610
Hypertonic Lactate After Cardiac Arrest
A Phase 2 study testing Sodium Lactate Solution in people with Cardiac Arrest and Ischemia Reperfusion Injury, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Ischemia Reperfusion Injury, Anoxic Brain Injury
- What is being tested?
- Sodium Lactate Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2025to 15 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age > 18 years old
- Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
- Comatose (GCS < 9)
- Time to ROSC > 15'
Who cannot join
- Protected categories (Pregnant women)
- Anticipated withdrawal of support within 24 hours
- Traumatic cause of cardiac arrest
- Body weight at admission > 120Kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fabio S Taccone, MD,PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital, Brussels University Hospital (HUB)
Brussels, Belgium, 1070
Fabio Silvio Taccone, MD, PhD
About this study
The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.
Read the detailed description
Background: In resuscitated patients after cardiac arrest, ischemic brain injury and cardiac depression due to the reperfusion injury are accountable for high mortality rate and poor outcome. Hypertonic sodium lactate (HSL) solutions have been proven to be safe in healthy volunteers and they have shown some benefits in patients with traumatic brain injury and those with myocardial ischemia and could decrease the burden of hypoxic lesions in these organs. The aim of this phase II study is to investigate whether HSL administration could reduce organ damage related biomarkers in serum and if the administrations of these solutions is safe and feasible in resuscitated patients after cardiac arrest.
Design: an investigator initiated, randomized, controlled, open label phase II clinical trial to test the safety and efficacy of the infusion of HSL in resuscitated patients after cardiac arrest admitted to the hospital. After resuscitation from CA, comatose patients will be screened for eligibility and randomized to receive either study treatment as HSL 1M infusion for 24h or standard of care.
Expected outcomes: This controlled trial will assess the safety and efficacy of the 1M HSL infusion in a cohort of comatose resuscitated patients after cardiac arrest. The results of this trial may provide useful information for a larger phase III clinical trial.
- Being tested
- Sodium Lactate Solution
- Keywords
- sodium lactate, cerebral metabolism
- Medical subject headings
- Heart Arrest, Reperfusion Injury, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Lactate SolutionDrug
Also called Hyperonic sodium lactate
continuous intravenous infusion of molar sodium lactate
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Patients will receive the standard of care infusion (balanced crystalloids) |
| treatement group | Experimental | Sodium lactate infusion 15 µmol/Kg/min Receives: Drug: Sodium Lactate Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum NSE
NSE serum levels
Measured: 48 hours after randomization
Secondary outcomes (15)
ICU length of stay
number of days in the intensive care unit
Measured: trough study completion, on average 30 days
Mortality
mortality
Measured: trough study completion before hospital discharge, on average 90 days
Neurological outcome
Neurological outcome measured by Cerebral Performance Category score at 90 days (1-5, 1 meaning better Neurological outcome)
Measured: trough study completion, 90 days after randomization
Hospital length of stay
Hospital length of stay
Measured: trough study completion, on average 60 days
Vasopressors equivalent dose
Vasopressors equivalent dose during the first 48 hours after resuscitation
Measured: through study completion, during the first 48 hours after resuscitation
Seizure rate
Seizure rate
Measured: through study completion before ICU discharge, on average 14 days
Changes in cardiac biomarkers
Troponin I serum levels
Measured: at randomization, 24 hours, 48 hours and 72 hours after randomization
Changes in brain biomarkers
brain biomarkers including nfL and GFAP
Measured: at randomization, after 24 hours, 48 hours and 72 hours
Severe adverse events rate
Serious adverse events rate
Measured: during study drug administration/day 28 or ICU discharge or death
Changes in brain metabolism
Brain metabolism measured by PET-IRM
Measured: within 24h after randomization
Changes in brain perfusion
brain perfusion measured with early perfusion CT scan
Measured: within 24h after randomization
Changes in echocardiographic parameters (systolic)
Changes systolic cardiac function assessed by echocardiography
Measured: at randomization, at 24 hours and 48 hours after randomization
Changes in echocardiographic parameters (diastolic)
Changes diastolic cardiac function assessed by echocardiography
Measured: at randomization, at 24 hours and 48 hours after randomization
identification of optimal perfusion pressure
identification of optimal perfusion pressure with invasive neuromonitoring
Measured: through study completion, on average 30 days
identification of optimal cerebral oxygen tension
identification of optimal cerebral oxygen tension with invasive neuromonitoring
Measured: through study completion, on average 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start19 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filippo Annoni, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004610
- Sponsor's protocol ID
- SRB2021260
- Acronym
- LATTE
- Status last verified
- Feb 2025
- First submitted
- 30 Jul 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be available on reasonable request to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertonic Lactate After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05004610
- Acronym / sponsor ID
- LATTE / SRB2021260
- Keywords
- sodium lactate, cerebral metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 13 Aug 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.
The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.
Detailed description
Background: In resuscitated patients after cardiac arrest, ischemic brain injury and cardiac depression due to the reperfusion injury are accountable for high mortality rate and poor outcome. Hypertonic sodium lactate (HSL) solutions have been proven to be safe in healthy volunteers and they have shown some benefits in patients with traumatic brain injury and those with myocardial ischemia and could decrease the burden of hypoxic lesions in these organs. The aim of this phase II study is to investigate whether HSL administration could reduce organ damage related biomarkers in serum and if the administrations of these solutions is safe and feasible in resuscitated patients after cardiac arrest.
Design: an investigator initiated, randomized, controlled, open label phase II clinical trial to test the safety and efficacy of the infusion of HSL in resuscitated patients after cardiac arrest admitted to the hospital. After resuscitation from CA, comatose patients will be screened for eligibility and randomized to receive either study treatment as HSL 1M infusion for 24h or standard of care.
Expected outcomes: This controlled trial will assess the safety and efficacy of the 1M HSL infusion in a cohort of comatose resuscitated patients after cardiac arrest. The results of this trial may provide useful information for a larger phase III clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –Patients will receive the standard of care infusion (balanced crystalloids) |
| treatement group | Experimental | Drug: Sodium Lactate SolutionSodium lactate infusion 15 µmol/Kg/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
- Comatose (GCS < 9)
- Time to ROSC > 15'
Key exclusion criteria (4 listed)
- Protected categories (Pregnant women)
- Anticipated withdrawal of support within 24 hours
- Traumatic cause of cardiac arrest
- Body weight at admission > 120Kg
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 |
|---|---|---|
| Sodium Lactate SolutionAlso: Hyperonic sodium lactatecontinuous intravenous infusion of molar sodium lactate | Drug | treatement group |
Primary outcome
serum NSE
Time frame: 48 hours after randomization
NSE serum levels
15 secondary outcomes
ICU length of stay
Time frame: trough study completion, on average 30 days
Mortality
Time frame: trough study completion before hospital discharge, on average 90 days
Neurological outcome
Time frame: trough study completion, 90 days after randomization
Hospital length of stay
Time frame: trough study completion, on average 60 days
Vasopressors equivalent dose
Time frame: through study completion, during the first 48 hours after resuscitation
Seizure rate
Time frame: through study completion before ICU discharge, on average 14 days
Changes in cardiac biomarkers
Time frame: at randomization, 24 hours, 48 hours and 72 hours after randomization
Changes in brain biomarkers
Time frame: at randomization, after 24 hours, 48 hours and 72 hours
Severe adverse events rate
Time frame: during study drug administration/day 28 or ICU discharge or death
Changes in brain metabolism
Time frame: within 24h after randomization
Changes in brain perfusion
Time frame: within 24h after randomization
Changes in echocardiographic parameters (systolic)
Time frame: at randomization, at 24 hours and 48 hours after randomization
Changes in echocardiographic parameters (diastolic)
Time frame: at randomization, at 24 hours and 48 hours after randomization
identification of optimal perfusion pressure
Time frame: through study completion, on average 30 days
identification of optimal cerebral oxygen tension
Time frame: through study completion, on average 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No. IPD may be available on reasonable request to other researchers
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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.
Fabio S Taccone, MD,PhD contact
Filippo Annoni, MD principal investigator
Erasme University Hospital
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 Sodium Lactate Solution in people with Cardiac Arrest and Ischemia Reperfusion Injury, run by Erasme University Hospital at 1 site in Belgium.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Feb 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 Belgium. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filippo Annoni, MD (0483141483, filippo.annoni@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum NSE (time frame: 48 hours after randomization). 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 21 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.