LEVETIRACETAM for Septic shock

Inclusion criteria

• {"criterion_text":"- age ≥18 years"}
• {"criterion_text":"- hospitalized in intensive care for less than 96 hours with septic shock evolving for less than 24 hours, defined by : o a clinically or microbiologically documented infection and o a SOFA score ≥2 or an increase in SOFA ≥2 points if organ dysfunction was present prior to infection and o the need for vasopressor administration to maintain a mean arterial pressure ≥65mmHg and o lactatemia > 2mmol/L (18mg/dL) despite adequate vascular filling"}
• {"criterion_text":"- consent of patient, family member or inclusion in emergency situation without prior consent of patient or family member"}

Exclusion criteria

• {"criterion_text":"- Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures"}
• {"criterion_text":"- Nursing mothers"}
• {"criterion_text":"- Patient under guardianship or trusteeship"}
• {"criterion_text":"- Patient with moderate to severe dementia"}
• {"criterion_text":"- Patient with psychiatric history and/or suicide attempts"}
• {"criterion_text":"- Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease"}
• {"criterion_text":"- Concomitant treatment with Methotrexate during the administration of the investigational treatment"}
• {"criterion_text":"- Patients Not affiliated to a social security scheme or CMU"}
• {"criterion_text":"- Patientswho Participate in another interventional trial with a drug that could interact with levetiracetam or have an impact on the evaluation of the KiSS trial endpoints. In case of doubt, please contact the trial coordinating investigator."}
• {"criterion_text":"- Patients with Chronic or progressive central neurological pathologies of traumatic, inflammatory, vascular, infectious, neoplastic or degenerative origin, defined by cognitive impairment not allowing independent living or an IQCODE score > 4.5"}
• {"criterion_text":"- Patients with Severe head injury less than 3 months old"}
• {"criterion_text":"- Patients in a situation where active therapies are limited, or for whom the therapeutic commitment is not maximal"}
• {"criterion_text":"- Patients with Allergy to levetiracetam"}
• {"criterion_text":"- Minor patients"}
• {"criterion_text":"- Patients with Pregnancy in progress (bHCG blood or urine)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the KiSS study will be the number of days alive without delirium or coma at D14 following randomization.","definition_or_measurement_approach":"Number of days alive without delirium or coma at day 14 following randomization."}

Secondary endpoints

• {"endpoint_text":"- Mortality in intensive care, in hospital, at D28 and D90","definition_or_measurement_approach":"Mortality assessed in intensive care, in-hospital, at day 28 and at day 90."}
• {"endpoint_text":"- Overall survival at D90","definition_or_measurement_approach":"Overall survival measured at day 90."}
• {"endpoint_text":"- The number of days without mechanical ventilation at D28: the duration between the start and end of mechanical ventilation including invasive, non-invasive mechanical ventilation and high-flow oxygen therapy of the Optiflow™ type (Fisher &. Paykel, Courtabœuf, France). The use of non-invasive ventilation or CPAP for the treatment of sleep apnea or chronic obstructive or restrictive respiratory insufficiency are not taken into account. Translated with DeepL.com (free version)","definition_or_measurement_approach":"Number of days without mechanical ventilation at day 28; includes duration between start and end of invasive and non-invasive mechanical ventilation and high-flow oxygen therapy (Optiflow™). Excludes non-invasive ventilation/CPAP used for sleep apnea or chronic respiratory insufficiency."}
• {"endpoint_text":"- Number of days alive outside the intensive care unit at D28 and outside the hospital at D90","definition_or_measurement_approach":"Number of days alive outside ICU at day 28 and outside hospital at day 90."}
• {"endpoint_text":"- Cumulative incidence and type of epileptic seizures between D1 and D14","definition_or_measurement_approach":"Cumulative incidence and classification of epileptic seizures occurring between day 1 and day 14 (EEG or clinical seizures)."}
• {"endpoint_text":"- The time between cessation of sedation and awakening","definition_or_measurement_approach":"Time interval measured between stopping sedation and clinical awakening (among patients who do not die under sedation)."}
• {"endpoint_text":"- Severity of cognitive impairment at D90","definition_or_measurement_approach":"Severity of cognitive impairment assessed at day 90 (e.g., T-MoCA telephone Montreal Cognitive assessment test as described in objectives)."}
• {"endpoint_text":"- Severity of anxiety and depression at D90","definition_or_measurement_approach":"Severity of anxiety and depression assessed at day 90 (e.g., HADS as described in objectives)."}
• {"endpoint_text":"- Presence of post-traumatic stress at J90","definition_or_measurement_approach":"Presence of post-traumatic stress assessed at day 90 (e.g., IES-R score as described in objectives)."}
• {"endpoint_text":"- Health-related quality of life at D90","definition_or_measurement_approach":"Health-related quality of life measured at day 90 using EQ-5D questionnaire."}
• {"endpoint_text":"- Autonomy in daily life at D90","definition_or_measurement_approach":"Autonomy in daily living assessed at day 90 using the Katz ADL scale."}

France

Earliest CTIS Part Ii Submission Date

26-09-2024

Latest Decision Or Authorization Date

12-05-2025

Processing Time Days

228

Number Of Sites

12

Number Of Participants

280

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France