Table 1. Characteristics of Participants in the Primary Analysis in a Study of the Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilationa.
| Characteristic | No. (%) | |
|---|---|---|
| Baclofen (n = 159)b | Placebo (n = 155) | |
| Age, mean (SD), y | 57.4 (11.9) | 56.6 (11.1) |
| Men | 122/158 (77.2) | 131 (84.5) |
| Women | 36/158 (22.8) | 24 (15.5) |
| Body mass index, mean (SD) | 27.7 (7.6) | 26.7 (5.9) |
| Body mass index >30 | 50 (31.9) | 42 (27.1) |
| SAPS II, mean (SD)c | 49.0 (18.3) | 46.4 (15.4) |
| SOFA score, mean (SD)d | 8.3 (3.9) | 7.7 (3.9) |
| Medical history | n = 158 | |
| Diabetes | 23 (14.6) | 24 (15.5) |
| Cirrhosis | 26 (16.5) | 18 (11.6) |
| Child-Pugh B or C scoree | 13/26 (50.0) | 8/18 (44.4) |
| Prior upper gastrointestinal bleeding | 14/26 (53.8) | 9/18 (50.0) |
| Alcohol and substance use history | ||
| Active tobacco user | 99/158 (62.7) | 92 (59.4) |
| Pack-years, mean (SD)f | 35.3 (24.9) | 35.3 (17.2) |
| Units of alcohol intake per day, median (IQR)g | 5.0 (4.0-10.0) | 6.0 (4.0-10.0) |
| Prior alcohol withdrawal attemptsh | 29/158 (18.4) | 28 (18.1) |
| Positive alcohol blood test on admission | 21/156 (13.5) | 25 (16.1) |
| Alcohol abusei | 40/68 (58.8) | 51/80 (63.7) |
| Alcohol dependencei | 33/39 (84.6) | 31/49 (63.3) |
| Cannabis useh | 11/158 (7.0) | 7 (4.5) |
| Opioid dependenceh | 9/158 (5.7) | 7 (4.5) |
| Duration between hospital admission and ICU admission, median (IQR), d | 0.24 (0.01-1.01) | 0.26 (0.06-1.15) |
| Reason for hospital admission | ||
| Medical | 124/158 (78.5) | 123 (79.4) |
| Surgical | 34/158 (21.5) | 32 (20.6) |
| Domestic or public road accident related to alcohol intake | 19/34 (55.9) | 19/32 (59.4) |
| Mechanical ventilation on ICU admission | 69/158 (43.7) | 66 (42.6) |
| Mechanical ventilation within 24 h of ICU admission | 142/158 (89.9) | 133 (85.8) |
| Duration between ICU admission and intubation, median (IQR), d | 0.01 (0.0-0.17) | 0.01 (0.0-0.45) |
| Diagnosis in ICUj | n = 158 | |
| Acute respiratory distress syndrome | 36 (22.8) | 40 (25.8) |
| Septic shock | 34 (21.5) | 26 (16.8) |
| Acute respiratory failure | 18 (11.4) | 19 (12.3) |
| Altered mental statusk | 15 (9.5) | 13 (8.4) |
| Multiple trauma | 13 (8.2) | 16 (10.3) |
| Overdose or toxic ingestionl | 10 (6.3) | 4 (2.6) |
| Pancreatitis | 8 (5.1) | 7 (4.5) |
| Postoperative care | 7 (4.4) | 7 (4.5) |
| Delirium tremens | 4 (2.5) | 9 (5.8) |
| Otherm | 13 (8.2) | 14 (9.0) |
Abbreviations: IQR, interquartile range.
Details of missing data are shown in eTable 2 in Supplement 2.
One patient (of 159) in the baclofen group withdrew consent.
The Simplified Acute Physiology Score (SAPS) II ranges from 0 to 163, with higher scores indicating a greater severity of illness.22 It was calculated using age, type of admission (emergency surgery, elective surgery, medical patient), chronic diseases (acquired immunodeficiency syndrome, metastatic cancer, hematological malignancy), and the worst value for 12 physiological variables within the 24 hours after admission. SAPS II of 30 indicates 10% probability of death; 45, 34%; 50, 56%; and 80, 92%.
The Sequential Organ Failure Assessment (SOFA) score was used to assess the degree of dysfunction of 6 organ systems: respiratory, cardiovascular, coagulation, renal, neurologic, and hepatic. Each subscore ranges from 0 (healthy) to 4 (maximum severity of organ dysfunction). The overall score ranges from 0 to 24.23 An initial SOFA score up to 9 indicates a mortality of less than 33%.
Child-Pugh score is used to determine the prognosis of chronic liver disease and is calculated using 5 parameters: total bilirubin, serum albumin, prothrombin time, ascites, and hepatic encephalopathy. A score of 5 to 6 indicates Child-Pugh A (1-year survival, 100%); 7 to 9, Child-Pugh B (1-year survival, 80%); and 10 to 15, Child-Pugh C (1-year survival, 40%).24
Pack-years was calculated as packs smoked per day × years as a smoker.
Based on medical record or patient or next of kin declaration and was assessed according to the “standard” drink definition from the National Institute on Alcohol Abuse and Alcoholism (NIAAA; namely 1 unit contains approximately 14 g of alcohol).
Based on medical record or patient or next of kin declaration.
On ICU discharge, patients with a clear mental status (73 in the baclofen group and 85 in the placebo group) were subjected to the questionnaire of the Diagnostic and Statistical Manual of Mental Disorder, 4th Edition, adapted by the NIAAA, to detect alcohol use disorder (ie, alcohol abuse or dependence; eFigure 2 in Supplement 2).
Because 1 patient could have several diagnoses, only the main diagnosis that led to the admission in the ICU was noted, regardless of the indication for intubation.
Altered mental status was defined as Glasgow Coma Scale (GCS) score less than 15. The GCS score is the sum of scores for eye, verbal, and motor responses. The minimum score is 3, which indicates deep coma, and the maximum is 15, which indicates fully awake.
Alcohol or other drug overdose and self-poisoning with cardiotropic or psychotropic agents.
Other diagnoses in the intensive care unit (ICU) are listed in eTable 3 in Supplement 2.