Hypertonic Lactate After Cardiac Arrest

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.

• ICU length of stay [Срок оценки: trough study completion, on average 30 days]
• Mortality [Срок оценки: trough study completion before hospital discharge, on average 90 days]
• Neurological outcome [Срок оценки: trough study completion, 90 days after randomization]
• Hospital length of stay [Срок оценки: trough study completion, on average 60 days]
• Vasopressors equivalent dose [Срок оценки: through study completion, during the first 48 hours after resuscitation]
• Seizure rate [Срок оценки: through study completion before ICU discharge, on average 14 days]
• Changes in cardiac biomarkers [Срок оценки: at randomization, 24 hours, 48 hours and 72 hours after randomization]
• Changes in brain biomarkers [Срок оценки: at randomization, after 24 hours, 48 hours and 72 hours]
• Severe adverse events rate [Срок оценки: during study drug administration/day 28 or ICU discharge or death]
• Changes in brain metabolism [Срок оценки: within 24h after randomization]
• Changes in brain perfusion [Срок оценки: within 24h after randomization]
• Changes in echocardiographic parameters (systolic) [Срок оценки: at randomization, at 24 hours and 48 hours after randomization]