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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Centre Hospitalier General	Gonesse	France
Hopital Beaujon	Clichy	France
Gjirau Hgkzrumkybz Nefy Ehhwbpt	Orsay	France
Crrjbm Hjhlercydsq Scp Erjpqcgvtvjyrqzvgnjbyir	Etampes	France
Gkxeazooxw Hqgiophggdi Elxhzmmf Mdopjwiutvm Sdtfnt Vdhq	Eaubonne	France
Gzbmnd Hoxpudyvmfh Ucprytzxkhqjp Pswnr Pkaghygtajz Ee Nuelmgxuxpkm	Paris	France
Cvthvl Honiaidboel Uzqrsejnxsagq Dc Dykgo	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.01.2025

Trial locations

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.

Investigated diseases:

Septic shock

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 ID:

2023-510449-51-00

Protocol code:

APHP200068

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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