Clinical Trial: Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 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.

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: Occurrence (yes or no) of agitation-related adverse events [ Time Frame: at the end of treatment (22 days max) ]

Original Primary Outcome: Occurrence (yes or no) of agitation-related adverse events during treatment/placebo administration [ Time Frame: at the end of treatment (22 days max) ]

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: March 3, 2016
Date Started: June 2016
Date Completion: July 2018
Last Updated: January 17, 2017
Last Verified: January 2017