LATTE: Hypertonic Lactate After Cardiac Arrest
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 0.5M infusion for 24h or standard of care.
Expected outcomes: This controlled trial will assess the safety and efficacy of the 0.5 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: standard of care Patients will receive the standard of care infusion (balanced crystalloids) |
|
| Experimental: treatement group half molar sodium lactate infusion 15 µmol/Kg/min |
Drug: Sodium Lactate Solution
continuous intravenous infusion of half-molar sodium lactate
Other Names:
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Outcome Measures
Primary Outcome Measures
- serum NSE [48 hours after randomization]
NSE serum levels
Secondary Outcome Measures
- ICU free days [trough study completion, on average 30 days]
number of days free from intensive care unit
- Mortality [trough study completion before hospital discharge, on average 60 days]
mortality
- Neurological outcome [trough study completion, 90 days after randomization]
Neurological outcome measured by Glasgow Outcome Scale at 90 days
- Hospital length of stay [trough study completion, on average 60 days]
Hospital length of stay
- Severe adverse events rate [during study drug administration/day 28 or ICU discharge or death]
Serious adverse events rate
- Need for Vasopressors [through study completion, on average 14 days]
Need for vasopressors during hospitalization
- Seizure rate [through study completion before ICU discharge, on average 14 days]
Seizure rate
- Changes in cardiac biomarkers [at randomization, 24 hours, 48 hours and 72 hours after randomization]
Troponin I serum levels
- Changes in brain biomarkers [at randomization, after 24 hours, 48 hours and 72 hours]
brain biomarkers including nfL and GFAP
- Changes in brain metabolism [within 24h after randomization]
Brain metabolism measured by PET-IRM
- Changes in brain perfusion [within 24h after randomization]
brain perfusion measured with early perfusion CT scan
- Changes in echocardiographic parameters (systolic) [at randomization, at 24 hours and 48 hours after randomization]
Changes systolic cardiac function assessed by echocardiography
- Changes in echocardiographic parameters (diastolic) [at randomization, at 24 hours and 48 hours after randomization]
Changes diastolic cardiac function assessed by echocardiography
- identification of optimal perfusion pressure [through study completion, on average 30 days]
identification of optimal perfusion pressure with invasive neuromonitoring
- identification of optimal cerebral oxygen tension [through study completion, on average 30 days]
identification of optimal cerebral oxygen tension with invasive neuromonitoring
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age > 18 years old
-
Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
-
Comatose (GCS < 9)
-
Time to ROSC > 15'
Exclusion Criteria:
-
Protected categories (Pregnant women, Prisoners)
-
Anticipated withdrawal of support within 24 hours
-
Traumatic cause of cardiac arrest
-
time from ROSC to inclusion > 1hour
-
Inclusion in any other interventional trial
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Erasme University Hospital
Investigators
- Principal Investigator: Filippo Annoni, MD, Hôpital Erasme
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRB2021260