Table 1.
Baseline Characteristics
| Prespecified Subgroups ELAD (n = 96) | Prespecified Subgroups Control (n = 107) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Characteristics | ELAD (n = 96) | Control (n = 107) | MELD < 28 (n = 51) | MELD ≥ 28 (n = 45) | Age < 46.9 years (n = 43) | Age ≥ 46.9 years (n = 53) | MELD < 28 (n = 69) | MELD ≥ 28 (n = 38) | Age < 46.9 years (n = 58) | Age ≥ 46.9 years (n = 49) |
| Acute AH (group A) | 92 (95.8) | 101 (94.4) | 47 (92.2) | 45 (100) | 42 (97.7) | 50 (94.3) | 64 (92.8) | 37 (97.4) | 55 (94.8) | 46 (93.9) |
| AH superimposed on underlying liver disease not due to alcohol (group B) | 4 (4.2) | 6 (5.6) | 4 (7.8) | 0 (0) | 1 (2.3) | 3 (5.7) | 5 (7.2) | 1 (2.6) | 3 (5.2) | 3 (6.1) |
| Days between last alcohol and hospital admission | 19.8 ± 14.2 | 19.8 ± 16.2 | 17.7 ± 13.7 | 22.2 ± 14.5 | 17.8 ± 12.7 | 21.5 ± 15.1 | 16.9 ± 14.9 | 23.7 ± 17.7 | 18.9 ± 16.7 | 19.7 ± 15.7 |
| Days between site admission and randomization | 10 ± 6.1 | 9.4 ± 7.8 | 8.3 ± 5.8 | 12.0 ± 5.9 | 9.2 ± 5.7 | 10.7 ± 6.4 | 7.8 ± 4.9 | 12.3 ± 10.8 | 9.7 ± 9.1 | 9.0 ± 5.9 |
| Age, years | 46.5 ± 9.1 | 44.8 ± 10.7 | 45.6 ± 8.4 | 47.5 ± 9.8 | 38.2 ± 5.6 | 53.2 ± 4.7 | 45.8 ± 10.7 | 43.0 ± 10.5 | 36.6 ± 5.9 | 54.4 ± 5.8 |
| Sex | ||||||||||
| Males | 55 (57.3) | 65 (60.7) | 25 (49.0) | 30 (66.7) | 22 (51.2) | 33 (62.3) | 40 (58.0) | 25 (65.8) | 33 (56.9) | 32 (65.3) |
| Females | 41 (42.7) | 42 (39.3) | 26 (51.0) | 15 (33.3) | 21 (48.8) | 20 (37.7) | 29 (42.0) | 13 (34.2) | 25 (43.1) | 17 (34.7) |
| Subjects with infection and systemic antibiotics | 58 (60.4) | 58 (54.2) | 27 (52.9) | 31 (68.9) | 26 (60.5) | 32 (60.4) | 36 (52.2) | 22 (57.9) | 33 (56.9) | 25 (51.0) |
| >2 episodes of dialysis in last week | 2 (2.1) | 0 (0) | 0 (0) | 2 (4.4) | 0 (0) | 2 (3.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Intubated | 8 (8.3) | 3 (2.8) | 5 (9.8) | 3 (6.7) | 6 (14.0) | 2 (3.8) | 1 (1.4) | 2 (5.3) | 1 (1.7) | 2 (4.1) |
| Encephalopathy grade | ||||||||||
| 0 | 52 | 54 | 32 | 20 | 25 | 27 | 35 | 19 | 26 | 28 |
| 1‐2 | 39 | 41 | 18 | 21 | 17 | 22 | 26 | 15 | 29 | 12 |
| 3‐4 | 3 | 9 | 1 | 2 | 1 | 2 | 6 | 3 | 3 | 6 |
| On vasopressors | 18 (18.8) | 20 (18.7) | 3 (5.9) | 15 (33.3) | 5 (11.6) | 13 (24.5) | 7 (10.1) | 13 (34.2) | 11 (19.0) | 9 (18.4) |
| Bilirubin from baseline MELD, mg/dL | 26.21 ± 9.7 | 24.07 ± 8.3 | 23.0 ± 7.9 | 29.8 ± 10.3 | 24.8 ± 8.0 | 27.4 ± 10.8 | 22.1 ± 7.8 | 27.7 ± 8.2 | 23.8 ± 9.4 | 24.4 ± 6.9 |
| INR | 2.0 ± 0.6 | 2.1 ± 0.5 | 1.8 ± 0.3 | 2.3 ± 0.6 | 2.0 ± 0.5 | 2.0 ± 0.6 | 1.8 ± 0.4 | 2.4 ± 0.5 | 2.2 ± 0.5 | 1.9 ± 0.5 |
| Creatinine, mg/dL | 1.1 ± 0.9 | 0.9 ± 0.5 | 0.7 ± 0.3 | 1.5 ± 1.2 | 0.9 ± 0.6 | 1.2 ± 1.1 | 0.8 ± 0.3 | 1.3 ± 0.6 | 0.9 ± 0.6 | 0.9 ± 0.4 |
| MELD | 27.6 ± 3.9 | 27.1 ± 3.8 | 24.5 ± 1.9 | 31.1 ± 2.4 | 27.0 ± 3.3 | 28.0 ± 4.4 | 24.7 ± 1.9 | 31.3 ± 2.3 | 27.8 ± 3.8 | 26.2 ± 3.6 |
| Albumin, g/dL | 2.8 ± 0.7 | 2.6 ± 0.6 | 2.7 ± 0.6 | 3.0 ± 0.7 | 2.8 ± 0.6 | 2.8 ± 0.8 | 2.5 ± 0.6 | 2.9 ± 0.7 | 2.7 ± 0.7 | 2.6 ± 0.6 |
| AST, U/L | 129.2 ± 60.9 | 140.9 ± 81.4 | 137.3 ± 64.4 | 120.1 ± 56.3 | 130.3 ± 62.2 | 128.2 ± 60.5 | 151.0 ± 83.9 | 122.7 ± 74.2 | 143.0 ± 90.7 | 138.5 ± 69.7 |
| ALT, U/L | 61.3 ± 44.1 | 61.4 ± 38.9 | 58.0 ± 42.5 | 65.1 ± 45.9 | 56.1 ± 44.6 | 65.5 ± 43.6 | 63.9 ± 42.8 | 57.0 ± 30.7 | 57.9 ± 30.9 | 65.6 ± 46.7 |
| WBC, 109/L | 15.4 ± 8.0 | 14.4 ± 8.1 | 14.1 ± 6.8 | 16.8 ± 9.0 | 15.7 ± 7.5 | 15.0 ± 8.4 | 13.3 ± 7.7 | 16.5 ± 8.5 | 14.9 ± 9.5 | 13.9 ± 6.2 |
| Liver size ultrasound | 19.1 ± 4.8 | 19.3 ± 3.9 | 18.6 ± 4.8 | 18.9 ± 4.7 | 20.8 ± 5.0 | 17.8 ± 4.2 | 19.5 ± 3.7 | 19.1 ± 4.2 | 19.7 ± 4.0 | 18.8 ± 3.8 |
| Ascites present | 55 | 65 | 25 | 30 | 31 | 34 | 39 | 26 | 37 | 28 |
| On steroids | 44 (45.8) | 53 (49.5) | 24 (47.1) | 20 (44.4) | 20 (46.5) | 24 (45.3) | 39 (56.5) | 14 (36.8) | 27 (46.6) | 26 (53.1) |
| On pentoxifylline | 33 (34.4) | 34 (31.8) | 17 (33.3) | 16 (35.6) | 14 (32.6) | 19 (35.8) | 21 (30.4) | 13 (34.2) | 27 (46.6) | 7 (14.3) |
NOTE: Data are given as n (%) or mean ± SD. Table 1 provides the baseline characteristics of all subjects as well as of the predefined subgroups regarding age and baseline. MELD. With the exception of a higher ratio of younger patients in the control arm, none of the baseline characteristics reached statistical difference by either unpaired comparison (t test or Mann‐Whitney U test were appropriate) or chi‐square analysis for distribution analysis.