Evaluation of Early Administration of Levetiracetam in the Prevention and Treatment Encephalopathy in Septic Shock: Randomized, Double-blind, Placebo-controlled Trial

Inclusion criteria

• Aged 18 years or older
• Hospitalized in intensive care for less than 96 hours
• Presenting with septic shock evolving for less than 24 hours defined by:

• Clinically or microbiologically documented infection and
• SOFA score ≥ 2 or an increase in SOFA score ≥ 2 points if organ dysfunction was present before the infection and
• Need for vasopressor administration to maintain a mean arterial pressure ≥ 65mmHg and
• Lactate level > 2mmol/L (18mg/dL) despite adequate fluid resuscitation
• Patient's consent, their next of kin consent, or emergency inclusion

Non inclusion criteria :

• Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
• Chronic or progressive central neurological pathologies of traumatic, inflammatory, vascular, infectious, neoplastic, or degenerative origin, defined by cognitive impairments preventing independent living or an IQCODE score > 4.5
• Patient with moderate to severe dementia
• Patient with psychiatric history and/or suicide attempts
• Severe head trauma within the past 3 months
• Patients with limitations on active therapies or for whom therapeutic commitment is not maximal
• Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease
• Concomitant treatment with Methotrexate during the administration of the investigational treatment
• Allergy to levetiracetam
• Minor patients
• Ongoing pregnancy (blood or urinary βHCG)
• Breastfeeding women
• Patients under guardianship or trusteeship
• Non-affiliation with social security or CMU
• Participation in another interventional trial with a drug that may interact with levetiracetam or may impact the evaluation of KiSS trial outcomes. In case of doubt, please contact the trial's coordinating investigator.