BridgeMD
KISS Evaluation of early administration of Levetiracetam in the prevention and treatment of delirium during septic shock: a randomized, double-blind, placebo-controlled trial.
EU CTIS ID: 2023-510449-51-00
What this study is testing
To assess the impact of early 7-day administration of levetiracetam in patients with septic shock hospitalized in the ICU on the number of days alive without coma or delirium at D14.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- age ≥18 years
- 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
- consent of patient, family member or inclusion in emergency situation without prior consent of patient or family member
You likely can't join if
- Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
- Nursing mothers
- Patient under guardianship or trusteeship
- Patient with moderate to severe dementia
- Patient with psychiatric history and/or suicide attempts
- Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease
See the full eligibility criteria
- age ≥18 years
- 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
- consent of patient, family member or inclusion in emergency situation without prior consent of patient or family member
- Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
- Nursing mothers
- Patient under guardianship or trusteeship
- Patient with moderate to severe dementia
- Patient with psychiatric history and/or suicide attempts
- Patient presenting a prolonged QTc interval on ECG and/or at risk of cardiovascular disease
- Concomitant treatment with Methotrexate during the administration of the investigational treatment
- Patients Not affiliated to a social security scheme or CMU
- 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.
- 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
- Patients with Severe head injury less than 3 months old
- Patients in a situation where active therapies are limited, or for whom the therapeutic commitment is not maximal
- Patients with Allergy to levetiracetam
- Minor patients
- Patients with Pregnancy in progress (bHCG blood or urine)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.