Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU (BACLOREA)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Alcoholism

Treatments: Drug: BACLOFEN; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT02723383

RC15_0036

Details and patient eligibility

About

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.

Enrollment: 314 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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314 participants in 2 patient groups, including a placebo group

BACLOFEN

Experimental group

Description:

patient will receive baclofen caps

Treatment:

Drug: BACLOFEN

PLACEBO

Placebo Comparator group

Description:

patient will receive placebo caps (lactose)

Treatment:

Drug: PLACEBO