drugset / Trial / NCT06851078

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

NCT06851078

Phase 3 Not yet recruiting 280 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-03-15
Primary completion
2027-06-15
Completion
2027-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Levetiracetam Other / unclassified 1000 mg Intravenous