Last updated on June 2018

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU


Brief description of study

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 twelve 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 June 2018.

Clinical Study Identifier: NCT02723383

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Sigismond LASOCKI

CHU ANGERS - r animation chirurgicale
Angers, France
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Jean-Baptiste LASCARROU

CHD La Roche Sur YON
La Roche Sur Yon, France
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Boris JUNG

CHU MONTPELLIER - Lapeyronie
Montpellier, France
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Samir JABER

Chu Montpellier
Montpellier, France
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Pierre Joachim MAHE

CHU NANTES - r animation chirurgicale
Nantes, France
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NOELLE BRULE

CHU NANTES -r animation m dicale
Nantes, France
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Thomas LESCOT

Hopital Saint Antoine
Paris, France
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Claire Dahyot-Fizelier

Chu Poitiers
Poitiers, France
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Yann-Mickaël MORICONI

Ch Cornouaille
Quimper, France
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Arnaud GACOUIN

Chu Rennes
Rennes, France
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Maud JONAS

CHR Saint Nazaire
Saint Nazaire, France
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Martine FERRANDIERE

Chu Tours
Tours, France
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Olivier HUET

CHU de Brest R animation Chirurgicale
Brest, France
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Erwan L'HER, MD

CHU de Brest R animation M dicale
Brest, France
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Damien Du Cheyron, MD

CHU de Caen R animation M dicale
Caen, France
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Christophe GUITTON

CH Le Mans
Le Mans, France
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Roland SMONIG, MD

Centre Hospitalier de Bretagne Sud R animation Polyvalente Lorient
Lorient, France
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Stephan EHRMANN, MD

CHRU Tours Bretonneau
Tours, France
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