Hypertonic Lactate After Cardiac Arrest
- Conditions
- Cardiac ArrestIschemia Reperfusion InjuryAnoxic Brain Injury
- Interventions
- Registration Number
- NCT05004610
- Lead Sponsor
- Erasme University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Age > 18 years old
- Sustained (> 20 minutes) return of spontaneous circulation (ROSC)
- Comatose (GCS < 9)
- Time to ROSC > 15'
- Protected categories (Pregnant women)
- Anticipated withdrawal of support within 24 hours
- Traumatic cause of cardiac arrest
- Body weight at admission > 120Kg
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description treatement group Sodium Lactate Solution Sodium lactate infusion 15 µmol/Kg/min
- Primary Outcome Measures
Name Time Method serum NSE 48 hours after randomization NSE serum levels
- Secondary Outcome Measures
Name Time Method Hospital length of stay trough study completion, on average 60 days Hospital length of stay
ICU length of stay trough study completion, on average 30 days number of days in the intensive care unit
Mortality trough study completion before hospital discharge, on average 90 days mortality
Neurological outcome trough study completion, 90 days after randomization Neurological outcome measured by Cerebral Performance Category score at 90 days (1-5, 1 meaning better Neurological outcome)
Vasopressors equivalent dose through study completion, during the first 48 hours after resuscitation Vasopressors equivalent dose during the first 48 hours after resuscitation
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
Severe adverse events rate during study drug administration/day 28 or ICU discharge or death Serious adverse events rate
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
Trial Locations
- Locations (1)
Erasme Hospital, Brussels University Hospital (HUB)
🇧🇪Brussels, Belgium