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Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU (BACLOREA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02723383
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE June 27, 2016
Actual Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
Occurrence (yes or no) of agitation-related adverse events during treatment/placebo administration [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2018)
  • Adverse event (yes or no) related to agitation [ Time Frame: within 28 days of ICU admission ]
  • Extubation failure defined as reintubation [ Time Frame: within the next 48 hours after extubation ]
  • Tracheotomy for failure of mechanical ventilation weaning during hospitalization [ Time Frame: an average of 28 days ]
  • Infections acquired in the ICU: Urinary infection, pneumonia, catheter infection or bacteraemia during hospitalization [ Time Frame: an average of 28 days ]
  • Total doses of sedatives and painkillers received in the ICU [ Time Frame: within 28 days of ICU admission ]
  • Riker Sedation -Agitation Scale (SAS) in the ICU [ Time Frame: within 28 days of ICU admission ]
  • Daily CIWA-Ar alcohol withdrawal score [ Time Frame: during the week following extubation ]
  • Duration of mechanical ventilation during hospitalization [ Time Frame: an average of 28 days ]
  • Ventilation free days (VFD) [ Time Frame: at day 28 ]
  • Length of ICU stay [ Time Frame: within 90 days ]
  • Length of total hospitalisation [ Time Frame: within 90 days ]
  • Death in ICU [ Time Frame: at days 28 and 90 ]
  • Death during hospital stay during hospitalization [ Time Frame: within 90 days ]
  • Number of adverse event (s) per patient occurring in ICU from Day 1 to Day 28 [ Time Frame: until Day 28 ]
  • Agitation requiring rapid intravenous or intramuscular administration of an hypnotic or neuroleptic (bolus) [ Time Frame: until Day 28 ]
  • Reintubation due to restlessness or withdrawal syndrome [ Time Frame: until Day 28 ]
  • Agitation and mortality in ICU at Day 28 [ Time Frame: at Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Adverse event (yes or no) related to agitation [ Time Frame: within 28 days of ICU admission ]
  • Extubation failure defined as reintubation [ Time Frame: within the next 48 hours after extubation ]
  • Tracheotomy for failure of mechanical ventilation weaning during hospitalization [ Time Frame: an average of 28 days ]
  • Infections acquired in the ICU: Urinary infection, pneumonia, catheter infection or bacteraemia during hospitalization [ Time Frame: an average of 28 days ]
  • Total doses of sedatives and painkillers received in the ICU [ Time Frame: within 28 days of ICU admission ]
  • Riker Sedation -Agitation Scale (SAS) in the ICU [ Time Frame: within 28 days of ICU admission ]
  • Daily CIWA-Ar alcohol withdrawal score [ Time Frame: during the week following extubation ]
  • Duration of mechanical ventilation during hospitalization [ Time Frame: an average of 28 days ]
  • Ventilation free days (VFD) [ Time Frame: at day 28 ]
  • Length of ICU stay [ Time Frame: within 90 days ]
  • Length of total hospitalisation [ Time Frame: within 90 days ]
  • Death in ICU [ Time Frame: at days 28 and 90 ]
  • Death during hospital stay during hospitalization [ Time Frame: within 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU
Official Title  ICMJE Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: BACLOFEN
    patient will receive baclofen caps
    Intervention: Drug: BACLOFEN
  • Placebo Comparator: PLACEBO
    patient will receive placebo caps (lactose)
    Intervention: Drug: PLACEBO
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2016)
314
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 14, 2019
Actual Primary Completion Date August 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723383
Other Study ID Numbers  ICMJE RC15_0036
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP