Please select the eligibility criteria that correspond to the clinical trial below.
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 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.


Options:
A: Inclusion Criteria:

* ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for \>10 years.
* Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Willingness to give written informed consent
* Abstinence from alcohol for between 3 and 21 days
* Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria:

* Active major psychological disorder associated with psychosis or significant suicide risk
* Pregnancy or lactation
* Concurrent use of any psychotropic medication other than antidepressants
* Substance use other than nicotine if unstable
* Clinical evidence of persisting hepatic encephalopathy
* Pending incarceration
* Lack of stable housing
* Active peptic ulcers
* Unstable diabetes mellitus
B: Inclusion Criteria:

* age ranging from 18 to 75 years
* diagnosis of alcohol dependence according to DSM IV criteria
* diagnosis of liver cirrhosis
* alcohol intake of at least 2 heavy drinking days (men \> 5 drinks/days; women \> 4 drinks/day) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to enrolment
* presence of a referred family member

Exclusion Criteria:

* severe heart or lung disease
* kidney alterations and/or hepato-renal syndrome
* tumours, including hepatocellular carcinoma
* metabolic diseases, including diabetes
* clinical signs of hepatic encephalopathy
* patients treated with interferon or corticosteroids within the last 60 days
* psychopathological illness undergoing treatment with psychoactive drugs
* epilepsy or epileptiform convulsions
* addiction to drugs other than nicotine
C: Inclusion criteria:

To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:

1. patient (or legal guardian) has been informed of the study procedures and has given written informed consent
2. patient experienced last stroke \> 6 months prior to enrollment
3. patient presents spasticity in at least 2 extremities
4. patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
5. patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm. A patient does not reach his/her therapy goal with other treatment interventions
6. stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
7. if female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
8. patient/family is willing to comply with study protocol including attending the study visits

Exclusion criteria:

To be eligible for inclusion in this study the patients must not meet any of the following criteria:

1. patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
2. patient has known hypersensitivity to baclofen
3. active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites)
4. presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
5. uncontrolled refractory epilepsy
6. use of oral vitamin K antagonists, e.g. warfarin/coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin, aggrenox, fragmin, plavix, ticlid) for the period of ITB test and implant
7. patient is pregnant or breastfeeding
8. patient received a Botulinum toxin injection less than 4 months ago
D: 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

Answer: D