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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Erasme Hospital, Brussels University Hospital (HUB)
Brussels, Belgium, Belgium
Start Date
February 19, 2025
Primary Completion Date
December 31, 2027
Completion Date
May 15, 2028
Last Updated
February 21, 2025
125
ESTIMATED participants
Sodium Lactate Solution
DRUG
Lead Sponsor
Erasme University Hospital
NCT07438938
NCT07363772
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