Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
Brief 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.


Options:
A: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: Baclofen 30mg/day | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Drug: Baclofen 75mg/day | Arm Label: Arm 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Baclofen 30mg/day; Assigned to Arm(s): Arm 1 | Intervention Type: DRUG; Name: Baclofen 75mg/day; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arm 3
B: Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Baclofen | Intervention Type: DRUG; Name: Baclofen; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 2
C: Arm Label: ITB therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: intrathecal baclofen | Arm Label: Best Medical Treatment (BMT); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: intrathecal baclofen; Assigned to Arm(s): ITB therapy
D: Arm Label: BACLOFEN; Type: EXPERIMENTAL; Interventions: Drug: BACLOFEN | Arm Label: PLACEBO; Type: PLACEBO_COMPARATOR; Interventions: Drug: PLACEBO | Intervention Type: DRUG; Name: BACLOFEN; Assigned to Arm(s): BACLOFEN | Intervention Type: DRUG; Name: PLACEBO; Assigned to Arm(s): PLACEBO

Answer: D