Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU (BACLOREA)
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|ClinicalTrials.gov Identifier: NCT02723383|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : January 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: BACLOFEN Drug: PLACEBO||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU: Study Protocol for a Randomised Controlled Against Placebo Trial|
|Actual Study Start Date :||June 27, 2016|
|Actual Primary Completion Date :||August 14, 2019|
|Actual Study Completion Date :||August 14, 2019|
patient will receive baclofen caps
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)
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.
- 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.
- 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 ]
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