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A Study of Levetiracetam for Prevention and Treatment of Delirium in Adult ICU Patients with Septic Shock

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with septic shock, a serious condition where infection leads to dangerously low blood pressure and organ dysfunction. The research examines whether early treatment with levetiracetam, a medication commonly used to treat seizures, can help prevent and treat confusion and altered mental state (known as delirium) that often occurs in patients with septic shock who are treated in the intensive care unit.

The study will compare two groups of patients - one receiving levetiracetam and another receiving placebo through an infusion into their veins. The medication or placebo will be given for seven days. The main goal is to determine if levetiracetam can increase the number of days that patients remain alert and free from confusion during their first two weeks of treatment.

Patients will be monitored for various outcomes, including their mental state, need for breathing support, and overall recovery. The study will also track long-term effects by following up with patients after three months to assess their thinking abilities, emotional well-being, and ability to perform daily activities. The treatment involves receiving either levetiracetam (up to 2000 mg per day) or sodium chloride solution as the placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and qualification

    Your eligibility for the study will be evaluated if you are an adult (age 18 or older) in intensive care with septic shock (a serious condition where infection affects blood pressure and organ function)

    You must be hospitalized in intensive care for less than 96 hours, with septic shock present for less than 24 hours

    Your medical condition will be assessed including blood pressure, blood tests, and organ function

  2. Step 2

    Treatment phase

    You will receive either levetiracetam or a placebo through an infusion (delivery of medication through a vein)

    The treatment will continue for 7 days

    Neither you nor your healthcare providers will know which treatment you are receiving

  3. Step 3

    14-day monitoring period

    Your condition will be monitored daily for 14 days

    Medical staff will assess your level of consciousness and check for signs of delirium (confused mental state)

    Any seizure activity will be documented

  4. Step 4

    28-day follow-up

    Your recovery will be monitored for 28 days

    Medical staff will track your breathing support needs

    The number of days you spend outside intensive care will be recorded

  5. Step 5

    90-day assessment

    A final evaluation will occur 90 days after starting the study

    Your mental function, emotional state, and quality of life will be assessed

    Your ability to perform daily activities independently will be evaluated

Who can join the trial?

9 criteria

  • Must be 18 years or older
  • Must be admitted to intensive care unit (ICU) for less than 96 hours (4 days) with septic shock that started within the last 24 hours
  • Must have a confirmed infection (through clinical examination or laboratory tests)
  • Must have organ dysfunction measured by a SOFA score of 2 or higher, or an increase in SOFA score by 2 points if organ problems existed before the infection (SOFA is a scoring system that measures how well different organs are functioning)
  • Must require medications to maintain blood pressure (vasopressors) to keep mean arterial pressure at or above 65mmHg
  • Must have high levels of lactate in the blood (more than 2 mmol/L or 18mg/dL) even after receiving proper fluid treatment (lactate is a substance that can indicate how well the body's tissues are receiving oxygen)
  • Must provide consent to participate, either:
    • directly from the patient
    • from a family member
    • or can be included in emergency situations without prior consent

Who cannot join the trial?

14 criteria

  • Age below 18 years old
  • Known epilepsy or history of seizures
  • Previous use of anti-epileptic medications
  • Known allergy or hypersensitivity to levetiracetam (the study medication)
  • Severe kidney failure requiring dialysis
  • Pregnant or breastfeeding women
  • Current participation in another clinical trial
  • Pre-existing brain injury or neurological conditions
  • Life expectancy less than 24 hours
  • Inability to obtain informed consent from patient or legal representative
  • History of severe liver disease
  • Patients with septic shock (a serious condition where infection causes dangerously low blood pressure) for more than 24 hours
  • Known psychiatric conditions requiring medication
  • Recent major surgery within the past 72 hours
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Investigated drugs

Levetiracetam is an anti-seizure medication that is being studied for preventing and treating delirium in patients with septic shock. It works by decreasing abnormal brain activity. In this trial, it is being tested to see if it can help patients remain free of confusion and altered mental states (delirium) when given early during septic shock treatment in the intensive care unit. The medication is typically used to treat epilepsy, but researchers are investigating its potential benefits in critically ill patients to prevent brain dysfunction.

What is already known about the treatment

Levetiracetam - An anticonvulsant medication administered intravenously or orally that is primarily used to treat epilepsy and prevent seizures, but is being investigated for delirium prevention in intensive care settings. The drug works by binding to the synaptic vesicle protein SV2A in the brain, helping to regulate neurotransmitter release and stabilize neuronal activity. Currently well-established in epilepsy treatment, levetiracetam is undergoing clinical trials to expand its therapeutic applications, particularly in critical care medicine for septic shock patients, where it shows potential in preventing and treating delirium, a common complication in intensive care units.

Investigated diseases

  • Septic shock

    A severe condition that occurs when an infection leads to dangerously low blood pressure. It develops as a complication of sepsis, where the body's response to infection causes inflammation throughout the body. During septic shock, blood flow to vital organs becomes significantly reduced, which can cause organs to stop working properly. The condition typically begins with an infection that spreads through the bloodstream, leading to widespread inflammation. Blood vessels become leaky and dilated, causing a dramatic drop in blood pressure that doesn't respond to simple fluid replacement. Patients often experience confusion, rapid breathing, and decreased urine output.

  • Delirium

    A serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment. The condition develops rapidly, usually within hours or days, and can fluctuate throughout the day. Delirium can cause hallucinations, disorientation, and changes in behavior, with affected individuals often having difficulty focusing attention or following conversations. People with delirium may experience changes in sleep patterns and levels of alertness.

  • Coma

    A state of deep unconsciousness in which a person cannot be awakened, fails to respond normally to painful stimuli, light, or sound, and lacks a normal sleep-wake cycle. During a coma, a person cannot initiate voluntary actions and is unaware of their surroundings. The condition can result from various causes, including infections, lack of oxygen, or severe illness. A person in a coma appears to be sleeping but cannot be awakened by external stimulation.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510449-51-00Protocol codeAPHP200068Estimated enrolment280 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).