CompletedPhase 3

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

France314 participantsStarted 2016-06-27

Plain-language summary

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients. Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day. Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults from 18 to 80 years old with an estimated alcohol intake of: * 14 units of alcohol per week during the month before hospitalisation for men aged 18 to 64 * 7 units of alcohol per week during the month before hospitalisation for women or men older than 65. AND Intubated, ventilated with an expected duration of mechanical ventilation\> 24 hours at least Exclusion Criteria: * Hospitalization \> 7 days * Baclofen administration before ICU admission (personal treatment or single administration) * Pregnancy * Porphyria * Burned on ICU admission * Personal treatment including Gamma-hydroxybutyric acid (Alcover/Xyrem) * Recent stroke or subarachnoid haemorrhage or head trauma with radiological evidence * Recent or old paraplegia or tetraplegia * Cardiac arrest with resuscitation manoeuvres before or after ICU admission * Contraindication to Enteral drug administration for longer than 24 hours * Lack of social protection * Hypersensitivity to Baclofen * Coeliac disease * Refractory epilepsy * Dementia, schizophrenia, Bipolar disorder or severe depression. * Parkinson's disease * Health care limitation owing to pejorative prognosis * Tracheotomy on ICU admission * Patients under guardianship or trusteeship * Patients already enrolled in interventional study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence (yes or no) of agitation-related adverse events

Timeframe: at the end of treatment (22 days max)

Trial details

NCT IDNCT02723383

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-14

View on ClinicalTrials.gov More Alcoholism trials