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NOT YET RECRUITING
NCT06851078
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Evaluation de l'Administration précoce de lévétiracétam Dans la prévention et le Traitement de l'encéphalopathie au Cours du Choc Septique : Essai randomisé, en Double Aveugle, contrôlé Par Placebo

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2025-03-15

Completion Date

2027-06-15

Last Updated

2025-03-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Levetiracetam IV

1000 mg twice a day during 7 days maximum

OTHER

Placebo control

NaCl 0.9% sodium chloride in the same route and method of administration as experimental treatment