Evaluation of early administration of Levetiracetam in the prevention and treatment of delirium during septic shock: a randomized, double-blind, placebo-controlled trial. KiSS
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
- 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
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
- 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)
- Patients with limitations on life-sustaining therapies or for whom therapeutic commitment is not maximal
- Chronic or progressive central neurological pathologies of traumatic, inflammatory, vascular, infectious, neoplastic, or degenerative origin, defined by cognitive impairments preventing independent living or an IQCODE score > 4.5
- Severe head trauma within the past 3 months
- Nursing mothers
- Patient under guardianship or trusteeship
- Patient with moderate to severe dementia
- Patients presenting with signs of depression and/or suicidal ideation or suicidal behavior and/or a history of suicide attempt(s)
- Patient With a prolonged QTc interval on ECG and/or any of the high arrhythmic-risk cardiovascular conditions defined below: • Congenital or acquired long QT syndrome (QTc ≥ 470 ms in males, ≥ 480 ms in females) or a history of torsades de pointes; • Documented history of sustained ventricular tachycardia, ventricular fibrillation, or arrhythmia-related cardiac arrest; • Inherited cardiac disease associated with a high risk of arrhythmia (including arrhythmogenic right ventricular cardiomyopathy, Brugada syndrome, and channelopathies); • Severe unstable heart failure (unstable NYHA class III–IV or recent decompensation).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- France
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, but 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.