Alcoholism Clinical Trial
Official title:
Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
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.
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