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

Phase 3

Not yet recruiting

• Conditions: Septic Shock
• Interventions: Drug: Levetiracetam IV; Other: Placebo control

• Registration Number: NCT06851078
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Sepsis-associated encephalopathy is associated with high mortality rates and long-term neuropsychiatric disorders. Currently, there is no specific treatment for sepsis-associated encephalopathy. Levetiracetam, a broad-spectrum antiepileptic widely used in intensive care units, has neuroprotective properties. We propose the KiSS study, a multicenter, prospective, randomized, double-blind trial with two arms, evaluating the effect of levetiracetam treatment for seven days during septic shock on the occurrence and duration of sepsis-associated encephalopathy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Start: 2025-03-15
• Primary Completion: 2027-06-15
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Levetiracetam administration	Levetiracetam IV	-
Placebo control	Placebo control	-

Primary Outcome Measures

Name	Time	Method
Number of days alive without delirium or coma	14 days after randomization

Secondary Outcome Measures

Name	Time	Method
Mortality in intensive care	At day 90
Mortality in hospital	At day 90
Overall survival	At day 90
Duration of mechanical ventilation	At day 28
Length of stay in intensive care unit	Up to day 90
Length of stay in hospital	Up to day 90
Occurrence of epileptic seizures	Up to day 14	From Day 1 to Day 14 (confirmed by EEG or tonic-clonic seizures) and/or occurrence of epileptic abnormalities (periodic epileptic discharges)
Time between cessation of sedation and awakening	At day 90	Defined by spontaneous eye opening, among patients not deceased under sedation
Severity of cognitive impairment	At day 90	Evaluated by a telephone survey using Telephone MoCA (Montreal Cognitive Assessment). The scores ranges from 0 to 30.; A score of 26 or higher is typically considered normal. A score of 25 or lower may indicate cognitive impairment, such as mild cognitive impairment (MCI) or early-stage dementia.
Severity of anxiety and depression	At day 90	Assessed with HADS (Hospital Anxiety and Depression Scale) scale Score varies from 0 to 21 for each componant (Anxiety and depression) The higher the score, the more severe the anxiety or depression.
Presence of post-traumatic stress (PTSD)	At day 90	Assessed by IES-R (Impact of Event Scale Revisited) The total score can range from 0 to 88. Higher scores indicate greater trauma-related distress and a higher likelihood of experiencing PTSD symptoms.
Quality of life scoring	At day 90	Using EQ-5D-5L. It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
Autonomy in daily life	At day 90	Using Katz Index of Independence in Activities of Daily Living (ADL) The score varies from 0 to 6, the lower the score, the more dependent the person.