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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
125
continuous intravenous infusion of molar sodium lactate
Erasme Hospital, Brussels University Hospital (HUB)
Brussels, Belgium, Belgium
RECRUITINGserum NSE
NSE serum levels
Time frame: 48 hours after randomization
ICU length of stay
number of days in the intensive care unit
Time frame: trough study completion, on average 30 days
Mortality
mortality
Time frame: 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)
Time frame: trough study completion, 90 days after randomization
Hospital length of stay
Hospital length of stay
Time frame: trough study completion, on average 60 days
Vasopressors equivalent dose
Vasopressors equivalent dose during the first 48 hours after resuscitation
Time frame: through study completion, during the first 48 hours after resuscitation
Seizure rate
Seizure rate
Time frame: through study completion before ICU discharge, on average 14 days
Changes in cardiac biomarkers
Troponin I serum levels
Time frame: at randomization, 24 hours, 48 hours and 72 hours after randomization
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Changes in brain biomarkers
brain biomarkers including nfL and GFAP
Time frame: at randomization, after 24 hours, 48 hours and 72 hours
Severe adverse events rate
Serious adverse events rate
Time frame: during study drug administration/day 28 or ICU discharge or death
Changes in brain metabolism
Brain metabolism measured by PET-IRM
Time frame: within 24h after randomization
Changes in brain perfusion
brain perfusion measured with early perfusion CT scan
Time frame: within 24h after randomization
Changes in echocardiographic parameters (systolic)
Changes systolic cardiac function assessed by echocardiography
Time frame: at randomization, at 24 hours and 48 hours after randomization
Changes in echocardiographic parameters (diastolic)
Changes diastolic cardiac function assessed by echocardiography
Time frame: at randomization, at 24 hours and 48 hours after randomization
identification of optimal perfusion pressure
identification of optimal perfusion pressure with invasive neuromonitoring
Time frame: through study completion, on average 30 days
identification of optimal cerebral oxygen tension
identification of optimal cerebral oxygen tension with invasive neuromonitoring
Time frame: through study completion, on average 30 days