Hypertonic Lactate After Cardiac Arrest A Phase II Randomized Controlled Trial of Sodium Lactate Infusion Versus Standard Care

What this Trial Is About

Researchers are evaluating whether an infusion of hypertonic sodium lactate can reduce brain damage in patients who have been resuscitated after a cardiac arrest. This phase II open-label clinical trial focuses on patients who are comatose following cardiac arrest, aiming to see if this treatment can safely lower brain injury markers in the blood compared to standard care. The study is motivated by the high mortality and poor outcomes caused by brain and heart injury after cardiac arrest, with previous research suggesting sodium lactate may help reduce such damage. Participants are randomly assigned to receive either a continuous intravenous infusion of hypertonic sodium lactate at a dose of 15 µmol/Kg/min for 24 hours or the standard care infusion with balanced crystalloids. This treatment begins shortly after resuscitation from cardiac arrest. The study's design compares these two approaches to evaluate the safety and potential benefits of sodium lactate in this critical setting. During the study, patients will be monitored closely with measurements of serum neuron-specific enolase (NSE) 48 hours after randomization as the primary outcome to assess brain injury. Additional evaluations include length of ICU and hospital stay, mortality rates, neurological status, cardiac and brain biomarkers, brain metabolism and perfusion, and echocardiographic heart function. Safety is also tracked by recording serious adverse events during treatment. Participants will be followed up for about 90 days after randomization to gather comprehensive data on outcomes and safety.

Hypertonic Lactate After Cardiac Arrest