Not Yet RecruitingPhase 3

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

280 participantsStarted 2025-03-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Number of days alive without delirium or coma

Timeframe: 14 days after randomization

Trial details

NCT IDNCT06851078

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-15

Contact for this trial

Shidasp Siami, MD

160807940 shidasp.siami@ch-sudessonne.fr

View on ClinicalTrials.gov More Septic Shock trials