Table 1:
Baseline characteristics
| Routine thermal management (n=215) | Induced hypothermia (n=217) | |
|---|---|---|
|
| ||
| Age (years) | 71 (65–77) | 70 (64–77) |
| Female sex | 87 (40%) | 86 (40%) |
| Weight (kg) | 75 (65–85) | 80 (65–86) |
| Body-mass index | 24.7 (22.5-27.8) | 24.9 (22.2-28.1) |
| Pre-existing conditions | ||
| Chronic obstructive pulmonary disease | 56 (26%) | 55 (25%) |
| Ischaemic heart disease | 12 (6%) | 24 (11%) |
| Diabetes | 44 (20%) | 37 (17%) |
| Heart failure | 8 (4%) | 14 (6%) |
| Liver cirrhosis | 18 (8%) | 10 (5%) |
| Chronic kidney disease | 6 (3%) | 17 (8%) |
| APACHE II score | 23 (17–29) | 23 (16–29) |
| SOFA score | 12 (11–14) | 13 (11–15) |
| Acute organ failure | ||
| Cerebral failure* | 143 (67%) | 173 (80%) |
| Coagulopathy† | 91/201 (45%) | 103/205 (50%) |
| Hepatic failure‡ | 51/200 (26%) | 57/206 (28%) |
| Renal failure§ | 37/207 (18%) | 66/209 (32%) |
| Receiving supportive therapy | ||
| Sedative | 209 (97%) | 214 (99%) |
| Vasoactive medication | ||
| Dopamine | 3 (1%) | 5 (2%) |
| Adrenaline | 13 (6%) | 20 (9%) |
| Noradrenaline | 206 (96%) | 210 (97%) |
| Dobutamine | 7 (3%) | 25 (12%) |
| Mechanical ventilation | 215 (100%) | 217 (100%) |
| Renal replacement therapy | 26 (12%) | 31 (14%) |
| Physiological variables | ||
| Mean arterial pressure (mm Hg)¶ | 66 (60–75) | 65 (60–74) |
| Lactate concentration (mmol/L) | 1.8 (1.3-2.9) | 1.9 (1.3-3.4) |
| Lactate concentration of >2 mmol/L | 87/214 (41%) | 90/212 (42%) |
| pH | 7.31 (7.24-7.39) | 7.29 (7.21–7.37) |
| PaO2 to FiO2 ratio (kPa) | 19.5 (13.2-28.2) | 20 (13–27) |
| Fibrin D-dimer concentration (mg/L) | 3.3 (1.6-6.6) | 37 (1.4–6.7) |
| APTT (s) | 37 (32–46) | 37 (32–46) |
| INR | 1.3 (1.1-1.5) | 1.3 (1.1–1.6) |
| Albumin concentration (g/L) | 24 (21–29) | 25 (20–29) |
| Bilirubin concentration (μmol/L) | 11 (7–21) | 13 (7–22) |
| Alkaline phosphatase concentration (U/L) | 90 (64–150) | 88 (68–140) |
| Creatinine concentration (μmol/L) | 98 (66–162) | 132 (74–212) |
| Fluid administration (mL/kg per h) | 4.0 (2.8-6.6) | 3.9 (2.6-7.1) |
| Fluid output (mL/kg per h) | 1.4 (0.7-2.6) | 1.5 (0.7–2.7) |
| Sodium concentration (mmol/L) | 139 (134–143) | 138 (134–142) |
| Potassium concentration (mmol/L) | 4.0 (3.7–4.5) | 4.1 (3.7–4.7) |
| Ionized Ca2+ concentration (mmol/L) | 1.14 (1.07-1.22) | 1.13 (1.06–1.20) |
| Temperature (°C) | 37.3 (36.5-38.2) | 37.2 (36.2–38.0) |
| C-reactive protein concentration (mg/L) | 150 (67–266) | 168 (78–277) |
| Leucocyte count (× 109per L) | 15 (11–22) | 15 (9–21) |
| Platelet count (× 109 per L) | 240 (146–320) | 195 (136–284) |
| Haemoglobin concentration (mmol/L) | 6.6 (5.8-7.9) | 6.6 (5.8–7.5) |
| Cooling method | ||
| Internal | .. | 15 (7%) |
| External | .. | 202 (93%) |
Data are median (IQR), n (%), or n/N (%). APACHE=Acute Physiology and Chronic Health Evaluation. SOFA=Sequential Organ Failure Assessment. PaO2=partial pressure of arterial oxygen. FiO2=fraction of inspired oxygen. APTT=activated partial thromboplastin time. INR=International Normalized Ratio. Ca2+=calcium ion.
RichmondAgitation-Sedation Scale of less than or equal to −4.
INR of more than or equal to 1.5 or platelet count of fewer than 150 × 109 per L.
Bilirubin concentration of more than 21 μmol/L.
Estimated glomerular filtration rate of less than 30 mL/min per 1.73 m2 or renal replacement therapy.
Less than 70 mm Hg at screening. Patients were actively resuscitated simultaneously with inclusion in the trial; therefore, mean arterial pressure could be slightly higher after inclusion than at screening.