Septic ShockPhase 3KiSSNCT06851078
Evaluation of Early Administration of Levetiracetam in the Prevention and Treatment Encephalopathy in Septic Shock: Randomized, Double-blind, Placebo-controlled Trial
A Phase 3 study testing Levetiracetam IV in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Levetiracetam IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Hospitalized in intensive care for less than 96 hours
- Presenting with septic shock evolving for less than 24 hours defined by:
- 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
Show all 24Show fewer
- Lactate level > 2mmol/L (18mg/dL) despite adequate fluid resuscitation
- Patient's consent, their next of kin consent, or emergency inclusion
- Non inclusion criteria :
- Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
- 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
- Patient with moderate to severe dementia
- Patient with psychiatric history and/or suicide attempts
- Severe head trauma within the past 3 months
- Patients with limitations on active therapies or for whom therapeutic commitment is not maximal
- 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
- Allergy to levetiracetam
- Minor patients
- Ongoing pregnancy (blood or urinary βHCG)
- Breastfeeding women
- Patients under guardianship or trusteeship
- Non-affiliation with social security or CMU
- Participation in another interventional trial with a drug that may interact with levetiracetam or may impact the evaluation of KiSS trial outcomes. In case of doubt, please contact the trial's coordinating investigator.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Septic Shock
- Being tested
- Levetiracetam IV, Placebo control
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levetiracetam IVDrug
1000 mg twice a day during 7 days maximum
Placebo controlOther
NaCl 0.9% sodium chloride in the same route and method of administration as experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| Early Levetiracetam administration | Experimental | Not described Receives: Drug: Levetiracetam IV |
| Placebo control | Placebo comparator | Not described Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days alive without delirium or coma
Measured: 14 days after randomization
Secondary outcomes (15)
Mortality in intensive care
Measured: At day 28
Mortality in intensive care
Measured: At day 90
Mortality in hospital
Measured: At day 28
Mortality in hospital
Measured: At day 90
Overall survival
Measured: At day 90
Duration of mechanical ventilation
Measured: At day 28
Length of stay in intensive care unit
Measured: Up to day 90
Length of stay in hospital
Measured: Up to day 90
Occurrence of epileptic seizures
From Day 1 to Day 14 (confirmed by EEG or tonic-clonic seizures) and/or occurrence of epileptic abnormalities (periodic epileptic discharges)
Measured: Up to day 14
Time between cessation of sedation and awakening
Defined by spontaneous eye opening, among patients not deceased under sedation
Measured: At day 90
Severity of cognitive impairment
Evaluated by a telephone survey using Telephone MoCA (Montreal Cognitive Assessment). The scores ranges from 0 to 30.
A score of 26 or higher is typically considered normal. A score of 25 or lower may indicate cognitive impairment, such as mild cognitive impairment (MCI) or early-stage dementia.
Measured: At day 90
Severity of anxiety and depression
Assessed with HADS (Hospital Anxiety and Depression Scale) scale Score varies from 0 to 21 for each componant (Anxiety and depression) The higher the score, the more severe the anxiety or depression.
Measured: At day 90
Presence of post-traumatic stress (PTSD)
Assessed by IES-R (Impact of Event Scale Revisited) The total score can range from 0 to 88. Higher scores indicate greater trauma-related distress and a higher likelihood of experiencing PTSD symptoms.
Measured: At day 90
Quality of life scoring
Using EQ-5D-5L. It evaluates five dimensions : mobility, self-care, usual activities, pain/discomfort and anxiety/depression and each dimension has five levels : no problems, slight problems, moderate problems, severe problems and extreme problems. Answers are given on a 5-point scale by domain, the higher the score, the poorer the quality of life.
Measured: At day 90
Autonomy in daily life
Using Katz Index of Independence in Activities of Daily Living (ADL) The score varies from 0 to 6, the lower the score, the more dependent the person.
Measured: At day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, multicenter, comparative, randomized, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851078
- Sponsor's protocol ID
- APHP200068
- Acronym
- KiSS
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06851078
- Acronym / sponsor ID
- KiSS / APHP200068
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase III, multicenter, comparative, randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Early Levetiracetam administration | Experimental | Drug: Levetiracetam IV |
| Placebo control | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Aged 18 years or older
- Hospitalized in intensive care for less than 96 hours
- Presenting with septic shock evolving for less than 24 hours defined by:
- Patient's consent, their next of kin consent, or emergency inclusion
- Chronic long-term antiepileptic treatment upon admission or patient with uncontrolled seizures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetam IV1000 mg twice a day during 7 days maximum | Drug | Early Levetiracetam administration |
| Placebo controlNaCl 0.9% sodium chloride in the same route and method of administration as experimental treatment | Other | Placebo control |
Primary outcome
Number of days alive without delirium or coma
Time frame: 14 days after randomization
15 secondary outcomes
Mortality in intensive care
Time frame: At day 28
Mortality in intensive care
Time frame: At day 90
Mortality in hospital
Time frame: At day 28
Mortality in hospital
Time frame: At day 90
Overall survival
Time frame: At day 90
Duration of mechanical ventilation
Time frame: At day 28
Length of stay in intensive care unit
Time frame: Up to day 90
Length of stay in hospital
Time frame: Up to day 90
Occurrence of epileptic seizures
Time frame: Up to day 14
Time between cessation of sedation and awakening
Time frame: At day 90
Severity of cognitive impairment
Time frame: At day 90
Severity of anxiety and depression
Time frame: At day 90
Presence of post-traumatic stress (PTSD)
Time frame: At day 90
Quality of life scoring
Time frame: At day 90
Autonomy in daily life
Time frame: At day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam IV in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shidasp Siami, MD (160807940 ext. +33, shidasp.siami@ch-sudessonne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days alive without delirium or coma (time frame: 14 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.