Table 1.
Demographic, Clinical and Biochemical Parameters in 1232 ALF patients with Grade III/IV Hepatic encephalopathy treated with therapeutic hypothermia (N=97) and controls (n=1135).
| No Hypothermia (control) group (N=1135) |
Hypothermia group (N=97) |
|||||
|---|---|---|---|---|---|---|
| N | Number (%) or median (IQR) |
N | Number (%) or median (IQR) |
P value | ||
| Age | 1135 | 40.0 (29.0 – 51.0) | 97 | 36.0 (29.0 – 46.0) | 0.03 | |
| Sex (female) | 1135 | 801 (70.6%) | 97 | 75 (77.3%) | 0.16 | |
| Race | 1135 | 97 | 0.88 | |||
| White | 865 (76.2%) | 76 (78.4%) | ||||
| African-American | 174 (15.3%) | 14 (14.4%) | ||||
| Other | 96 (8.5%) | 7 (7.2%) | ||||
| Ethnicity | 1133 | 95 | 0.13 | |||
| Hispanic/Latino | 92 (8.1%) | 12 (12.6%) | ||||
| Not Hispanic/Latino | 1041 (91.9%) | 83 (87.4%) | ||||
| Etiology | 1134 | 96 | 0.04 | |||
| Acetaminophen | 537 (47.4%) | 61 (63.5%) | ||||
| Viral hepatitis | 111 (9.8%) | 9 (9.4%) | ||||
| Drug Induced | 112 (9.9%) | 6 (6.3%) | ||||
| Indeterminate | 148 (13.1%) | 7 (7.3%) | ||||
| Other | 226 (19.9%) | 13 (13.5%) | ||||
| Admission biochemistry | ||||||
| Hemoglobin (g/dl) | 1125 | 10.6 (9.3 – 12.2) | 97 | 10.0 (8.9 – 12.0) | 0.10 | |
| White Blood count (x109/L) | 1130 | 10.8 (7.1 – 15.8) | 97 | 10.0 (6.6 – 15.1) | 0.30 | |
| Platelet count (x109/L) | 1128 | 124.5 (77.5 – 187.0) | 97 | 105.0 (70.0 – 172.0) | 0.10 | |
| INR | 1116 | 2.8 (2.0 – 4.4) | 97 | 3.0 (2.1 – 4.8) | 0.60 | |
| AST (IU/L) | 1122 | 1648.0 (524.0 – 5775.0) | 95 | 2315.0 (576.0 – 6109.0) | 0.32 | |
| ALT (IU/L) | 1118 | 1954.0 (697.0 – 4441.0) | 94 | 2651.0 (963.0 – 4500.0) | 0.19 | |
| Bilirubin (mg/dl) | 1123 | 7.1 (3.9 – 19.1) | 94 | 6.8 (4.3 – 11.8) | 0.39 | |
| pH | 993 | 7.4 (7.3 – 7.5) | 91 | 7.4 (7.4 – 7.5) | 0.37 | |
| Ammonia (venous; µmol/L) | 353 | 108.0 (73.0 – 168.0) | 54 | 116.0 (79.0 – 170.0) | 0.25 | |
| Creatinine (mg/dL) | 1134 | 2.0 (1.0 – 3.4) | 96 | 1.5 (1.0 – 3.1) | 0.08 | |
| Lactate (mmol/L) | 668 | 5.0 (3.0 – 10.2) | 65 | 5.4 (3.1 – 9.1) | 0.84 | |
| Phosphate (mg/dL) | 989 | 3.2 (2.1 – 4.8) | 92 | 2.8 (2.0 – 4.1) | 0.06 | |
| PO2/FiO2 ratio | 865 | 3.3 (2.1 – 4.4) | 87 | 3.4 (2.4 – 4.5) | 0.56 | |
| MELD (admission) | 1105 | 33.6 (27.4 – 40.2) | 93 | 32.1 (26.7 – 38.2) | 0.23 | |
| Target Temperature* | 1135 | 36.6 (36.1 – 37.0) | 97 | 34.1 (32.9 – 35.3) | <0.0001 | |
| Organ support (7-days)** | ||||||
| Mechanical ventilation | 1135 | 975 (85.9%) | 97 | 97 (100.0%) | <0.0001 | |
| Vasopressors | 1135 | 491 (43.3%) | 97 | 59 (60.8%) | 0.0008 | |
| Renal Replacement therapy | 1135 | 451 (39.7%) | 97 | 61 (62.9%) | <0.0001 | |
| ICP therapies (7-days) | ||||||
| Mannitol | 1135 | 304 (26.8%) | 97 | 60 (61.9%) | <0.0001 | |
| Hypertonic saline | 1134 | 64 (5.6%) | 97 | 33 (34.0%) | <0.0001 | |
| Barbiturates | 1135 | 105 (9.3%) | 97 | 16 (16.5%) | 0.02 | |
| Sedatives | 1135 | 873 (76.9%) | 97 | 88 (90.7%) | 0.002 | |
| ICP Monitor Placement | 1002 | 218 (21.8%) | 97 | 38 (39.2%) | 0.0001 | |
| Blood products (7-days) | ||||||
| Red Blood Cells | 1135 | 530 (46.7%) | 97 | 50 (51.6%) | 0.36 | |
| Fresh Frozen Plasma | 1135 | 768 (67.7%) | 97 | 80 (82.5%) | 0.003 | |
| Recombinant VIIA | 1134 | 19 (1.7%) | 97 | 7 (7.2%) | 0.0003 | |
| Platelets | 1135 | 330 (29.1%) | 97 | 38 (39.2%) | 0.04 | |
- Abbreviations: INR, international normalized ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase; pO2, partial pressure of oxygen, FiO2, fraction of inspired oxygen.
- **Median target temperature where available in the No Hypothermia Group over all inpatient days (up to 7) and in the hypothermia group over all inpatient days actively treated with hypothermia.
- **7-days: Values refer to therapies at any time during the 7-days of study