NCT02723383

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 27, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2019

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

3.1 years

First QC Date

March 3, 2016

Last Update Submit

January 28, 2020

Conditions

Alcoholism

Keywords

alcoholismintensive careBaclofenrestlessnessDelirium tremensAlcohol withdrawal syndrome

Outcome Measures

Primary Outcomes (1)

  • Occurrence (yes or no) of agitation-related adverse events

    Occurrence (yes or no) of agitation-related adverse events during treatment/placebo administration with at least one sign out of the following: * Unplanned extubation * Medical disposal removal * Falling out of bed * ICU runaway * Immobilization device removal * Self-aggression or aggression towards medical staff.

    at the end of treatment (22 days max)

Secondary Outcomes (17)

  • Adverse event (yes or no) related to agitation

    within 28 days of ICU admission

  • Extubation failure defined as reintubation

    within the next 48 hours after extubation

  • Tracheotomy for failure of mechanical ventilation weaning during hospitalization

    an average of 28 days

  • Infections acquired in the ICU: Urinary infection, pneumonia, catheter infection or bacteraemia during hospitalization

    an average of 28 days

  • Total doses of sedatives and painkillers received in the ICU

    within 28 days of ICU admission

  • +12 more secondary outcomes

Study Arms (2)

BACLOFEN

EXPERIMENTAL

patient will receive baclofen caps

Drug: BACLOFEN

PLACEBO

PLACEBO COMPARATOR

patient will receive placebo caps (lactose)

Drug: PLACEBO

Interventions

BACLOFENDRUG

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.

BACLOFEN
PLACEBODRUG

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.

PLACEBO

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults from 18 to 80 years old with an estimated alcohol intake of:
  • units of alcohol per week during the month before hospitalisation for men aged 18 to 64
  • 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

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU ANGERS - réanimation chirurgicale

Angers, France

Location

CHU de Brest Réanimation Chirurgicale

Brest, France

Location

CHU de Brest Réanimation Médicale

Brest, France

Location

CHU de Caen Réanimation Médicale

Caen, France

Location

CHD La Roche Sur YON

La Roche-sur-Yon, France

Location

CH Le Mans

Le Mans, France

Location

Centre Hospitalier de Bretagne Sud Réanimation Polyvalente Lorient

Lorient, France

Location

CHU MONTPELLIER - Lapeyronie

Montpellier, France

Location

Chu Montpellier

Montpellier, France

Location

CHU NANTES - réanimation chirurgicale

Nantes, France

Location

CHU NANTES -réanimation médicale

Nantes, France

Location

Hopital Saint Antoine

Paris, France

Location

Chu Poitiers

Poitiers, France

Location

Ch Cornouaille

Quimper, France

Location

Chu Rennes

Rennes, France

Location

CHR Saint Nazaire

Saint-Nazaire, France

Location

CHRU Tours Bretonneau

Tours, France

Location

Chu Tours

Tours, France

Location

Related Publications (2)

  • 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.

    PMID: 33620407DERIVED

  • 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.

    PMID: 27542731DERIVED

MeSH Terms

Conditions

AlcoholismPsychomotor AgitationAlcohol Withdrawal Delirium

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorAlcohol-Induced Disorders, Nervous SystemNeurotoxicity SyndromesPoisoningAlcohol-Induced DisordersSubstance Withdrawal Syndrome

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 30, 2016

Study Start

June 27, 2016

Primary Completion

August 14, 2019

Study Completion

August 14, 2019

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(18)