Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

PHASE3CompletedINTERVENTIONAL
Enrollment

314

Participants

Timeline

Start Date

June 27, 2016

Primary Completion Date

August 14, 2019

Study Completion Date

August 14, 2019

Conditions
Alcoholism
Interventions
DRUG

BACLOFEN

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.

DRUG

PLACEBO

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.

Trial Locations (18)

Unknown

CHU ANGERS - réanimation chirurgicale, Angers

CHU de Brest Réanimation Chirurgicale, Brest

CHU de Brest Réanimation Médicale, Brest

CHU de Caen Réanimation Médicale, Caen

CHD La Roche Sur YON, La Roche-sur-Yon

CH Le Mans, Le Mans

Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient, Lorient

CHU MONTPELLIER - Lapeyronie, Montpellier

Chu Montpellier, Montpellier

CHU NANTES - réanimation chirurgicale, Nantes

CHU NANTES -réanimation médicale, Nantes

Hopital Saint Antoine, Paris

Chu Poitiers, Poitiers

Ch Cornouaille, Quimper

Chu Rennes, Rennes

CHR Saint Nazaire, Saint-Nazaire

CHRU Tours Bretonneau, Tours

Chu Tours, Tours

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT02723383 - Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU | Biotech Hunter | Biotech Hunter