title: Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial.
abstract: 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, and psychiatric and cognitive impairment. Without appropriate treatment, delirium tremens can lead to death in up to 50 % of patients.
  
  
  
  This prospective, double-blind, randomised controlled study versus placebo will be conducted in twelve French intensive care units (ICU). Patients with an alcohol intake level higher than the NIAAA threshold, who are 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 the ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, and cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects in the ICU are defined as unplanned extubation, medical disposal removal (such as urinary catheter, venous or arterial line or surgical drain), falling out of bed, ICU runaway (leaving ICU without physician's approval), immobilisation device removal, self-aggression or aggression towards medical staff. Daily doses of baclofen/placebo will be guided by daily creatinine clearance assessment.
  
  
  
  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 October 2018.
  
  
  
  ClinicalTrials.gov Identifier: NCT02723383 , registered on 3 March 2016.
authors.affiliation: Departments of Anaesthesiology and Surgical Intensive Care, Hôtel-Dieu, University Hospital of Nantes, 44093, Nantes, France.
authors.forename: Mickael
authors.initials: M
authors.lastname: Vourc'h
authors.affiliation: Biometry Platform, Research Promotion Department, University Hospital of Nantes, 44093, Nantes, France.|EA 4275 SPHERE Methods for Patient-centered Outcomes and Health Research, Nantes University, 44035, Nantes, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Feuillet
authors.affiliation: Departments of Anaesthesiology and Surgical Intensive Care, Hôtel-Dieu, University Hospital of Nantes, 44093, Nantes, France.
authors.forename: Pierre-Joachim
authors.initials: PJ
authors.lastname: Mahe
authors.affiliation: Biometry Platform, Research Promotion Department, University Hospital of Nantes, 44093, Nantes, France.|EA 4275 SPHERE Methods for Patient-centered Outcomes and Health Research, Nantes University, 44035, Nantes, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Sebille
authors.affiliation: Departments of Anaesthesiology and Surgical Intensive Care, Hôtel-Dieu, University Hospital of Nantes, 44093, Nantes, France. Karim.asehnoune@chu-nantes.fr.
authors.forename: Karim
authors.initials: K
authors.lastname: Asehnoune
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000188:drug therapy*; D001418:Baclofen / Q000627:therapeutic use*; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011595:Psychomotor Agitation / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D001418:Baclofen
keywords: Alcohol withdrawal syndrome; Alcoholism; Baclofen; Delirium tremens; Intensive care; Restlessness