Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): BACLOFEN; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the treatment will be administered via the nasogastric feeding tube. After extubation, the treatment will be administered either via the nasogastric tube or the oral route.; Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the placebo will be administered via the nasogastric feeding tube. After extubation, the placebo will be administered either via the nasogastric tube or the oral route.
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: alcoholism; intensive care; Baclofen; restlessness; Delirium tremens; Alcohol withdrawal syndrome