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Trial record 23 of 128 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

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

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ClinicalTrials.gov Identifier: NCT02723383
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 twelve 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 June 2018.


Condition or disease Intervention/treatment Phase
Alcoholism Drug: BACLOFEN Drug: PLACEBO Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial
Study Start Date : June 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BACLOFEN
patient will receive baclofen caps
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.
Placebo Comparator: PLACEBO
patient will receive placebo caps (lactose)
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults from 18 to 70 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723383


Contacts
Contact: Karim ASEHNOUNE, Pr karim.asehnoune@chu-nantes.fr
Contact: Mickaël VOURC'H, MD vourchm@gmail.com

Locations
France
CHU ANGERS - réanimation chirurgicale Recruiting
Angers, France
Principal Investigator: Sigismond LASOCKI         
CHD La Roche Sur YON Recruiting
La Roche Sur Yon, France
Principal Investigator: Jean-Baptiste LASCARROU         
CHU MONTPELLIER - Lapeyronie Not yet recruiting
Montpellier, France
Principal Investigator: Boris JUNG         
Chu Montpellier Recruiting
Montpellier, France
Principal Investigator: Samir JABER         
CHU NANTES - réanimation chirurgicale Recruiting
Nantes, France
Principal Investigator: Pierre Joachim MAHE         
CHU NANTES -réanimation médicale Recruiting
Nantes, France
Principal Investigator: NOELLE BRULE         
Hopital Saint Antoine Recruiting
Paris, France
Principal Investigator: Thomas LESCOT         
Chu Poitiers Recruiting
Poitiers, France
Principal Investigator: Claire Dahyot-Fizelier         
Ch Cornouaille Recruiting
Quimper, France
Principal Investigator: Yann-Mickaël MORICONI         
Chu Rennes Recruiting
Rennes, France
Principal Investigator: Arnaud GACOUIN         
CHR Saint Nazaire Recruiting
Saint Nazaire, France
Principal Investigator: Maud JONAS         
Chu Tours Recruiting
Tours, France
Principal Investigator: Martine FERRANDIERE         
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02723383     History of Changes
Other Study ID Numbers: RC15_0036
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
alcoholism
intensive care
Baclofen
restlessness
Delirium tremens
Alcohol withdrawal syndrome

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs