Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

NCT ID: NCT02723383

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-27
• Study Completion Date: 2019-08-14

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

BACLOFEN

patient will receive baclofen caps

Group Type: EXPERIMENTAL

BACLOFEN

Intervention Type: DRUG

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.

PLACEBO

patient will receive placebo caps (lactose)

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults from 18 to 80 years old with an estimated alcohol intake of:

• 14 units of alcohol per week during the month before hospitalisation for men aged 18 to 64
• 7 units of alcohol per week during the month before hospitalisation for women or men older than 65.

AND Intubated, ventilated with an expected duration of mechanical ventilation> 24 hours at least

Exclusion Criteria

• Hospitalization > 7 days
• Baclofen administration before ICU admission (personal treatment or single administration)
• Pregnancy
• Porphyria
• Burned on ICU admission
• Personal treatment including Gamma-hydroxybutyric acid (Alcover/Xyrem)
• Recent stroke or subarachnoid haemorrhage or head trauma with radiological evidence
• Recent or old paraplegia or tetraplegia
• Cardiac arrest with resuscitation manoeuvres before or after ICU admission
• Contraindication to Enteral drug administration for longer than 24 hours
• Lack of social protection
• Hypersensitivity to Baclofen
• Coeliac disease
• Refractory epilepsy
• Dementia, schizophrenia, Bipolar disorder or severe depression.
• Parkinson's disease
• Health care limitation owing to pejorative prognosis
• Tracheotomy on ICU admission
• Patients under guardianship or trusteeship
• Patients already enrolled in interventional study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU ANGERS - réanimation chirurgicale

Angers, , France

CHU de Brest Réanimation Chirurgicale

Brest, , France

CHU de Brest Réanimation Médicale

Brest, , France

CHU de Caen Réanimation Médicale

Caen, , France

CHD La Roche Sur YON

La Roche-sur-Yon, , France

CH Le Mans

Le Mans, , France

Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient

Lorient, , France

CHU MONTPELLIER - Lapeyronie

Montpellier, , France

Chu Montpellier

Montpellier, , France

CHU NANTES - réanimation chirurgicale

Nantes, , France

CHU NANTES -réanimation médicale

Nantes, , France

Hopital Saint Antoine

Paris, , France

Chu Poitiers

Poitiers, , France

Ch Cornouaille

Quimper, , France

Chu Rennes

Rennes, , France

CHR Saint Nazaire

Saint-Nazaire, , France

CHRU Tours Bretonneau

Tours, , France

Chu Tours

Tours, , France

Countries

France

References

Vourc'h M, Garret C, Gacouin A, Lacherade JC, Jonas M, Klouche K, Ferrandiere M, Jaber S, Flet L, Dailly E, Pouplet C, Maamar A, Reignier J, Roquilly A, Feuillet F, Mahe PJ, Asehnoune K; BACLOREA study group. Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):732-741. doi: 10.1001/jama.2021.0658.

Reference Type: DERIVED

PMID: 33620407 (View on PubMed)

Vourc'h M, Feuillet F, Mahe PJ, Sebille V, Asehnoune K; BACLOREA trial group. Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial. Trials. 2016 Aug 19;17(1):415. doi: 10.1186/s13063-016-1539-2.

Reference Type: DERIVED

PMID: 27542731 (View on PubMed)

Other Identifiers

RC15_0036

Identifier Type: -

Identifier Source: org_study_id