Skip to main content
OpenTrials
Completed

NCT Number: NCT02723383

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholism Aberrant Motor Behavior in Dementia Alcohol Withdrawal Delirium Alcohol-Induced Disorders Alcohol-Induced Disorders, Nervous System Alcohol-Related Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neurotoxicity Syndromes Pathological Conditions, Signs and Symptoms Poisoning Psychomotor Agitation Psychomotor Disorders Signs and Symptoms Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU ANGERS - réanimation chirurgicale, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

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

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.

Primary outcomes

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

    Time frame: at the end of treatment (22 days max)

    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.

Secondary outcomes

  1. Adverse event (yes or no) related to agitation

    Time frame: within 28 days of ICU admission

  2. Extubation failure defined as reintubation

    Time frame: within the next 48 hours after extubation

  3. Tracheotomy for failure of mechanical ventilation weaning during hospitalization

    Time frame: an average of 28 days

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

    Time frame: an average of 28 days

  5. Total doses of sedatives and painkillers received in the ICU

    Time frame: within 28 days of ICU admission

  6. Riker Sedation -Agitation Scale (SAS) in the ICU

    Time frame: within 28 days of ICU admission

  7. Daily CIWA-Ar alcohol withdrawal score

    Time frame: during the week following extubation

  8. Duration of mechanical ventilation during hospitalization

    Time frame: an average of 28 days

  9. Ventilation free days (VFD)

    Time frame: at day 28

  10. Length of ICU stay

    Time frame: within 90 days

  11. Length of total hospitalisation

    Time frame: within 90 days

  12. Death in ICU

    Time frame: at days 28 and 90

  13. Death during hospital stay during hospitalization

    Time frame: within 90 days

  14. Number of adverse event (s) per patient occurring in ICU from Day 1 to Day 28

    Time frame: until Day 28

  15. Agitation requiring rapid intravenous or intramuscular administration of an hypnotic or neuroleptic (bolus)

    Time frame: until Day 28

  16. Reintubation due to restlessness or withdrawal syndrome

    Time frame: until Day 28

  17. Agitation and mortality in ICU at Day 28

    Time frame: at Day 28

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial

Acronym: BACLOREA

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2016
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.