TABLE 2.
ProCESS pre-intervention characteristics, stratified by receipt of initial EMS care.
| Characteristic | EMS Care (n=826) |
No EMS Care (n=515) |
Odds Ratio (95% CI) and P-values |
|---|---|---|---|
| Estimated prehospital intravenous fluids (ml) – median (IQR), min, max† | 500 (225-1000), 10, 5000 | -* | - |
| Emergency Department Presentation | |||
| Mechanical ventilation on ED arrival | 56 (6.8) | 9 (1.7)** | 4.09 (2.00-8.34) |
| Prior history of chronic invasive mechanical ventilation (n=61) | 13 (25.5) | 2 (20.0) | 1.37 (0.26-7.29) |
| Mental status comatose or near-comatose | 92 (11.1) | 14 (2.7) | 4.48 (2.53-7.96) |
| Pre-intervention normal or minimally impaired mental | 548 (66.3) | 368 (71.5) | 0.79 (0.62-1.00) |
| Pre-intervention lactate ≥4 mg/dL | 513 (62.1) | 287 (55.7) | 1.30 (1.04-1.63) |
| Pre-intervention lactate level (mg/dL) | 5.1 (3.3) | 4.6 (3.2) | P=0.01 |
| Refractory hypotension (SBP≤90 mm Hg) | 430 (52.1) | 297 (57.7) | 0.80 (0.64-0.99) |
| Pre-intervention systolic blood pressure - Mean (SD) | 102.5 (29.7) | 97.9 (27.0) | P=0.005 |
| Source of Infection | |||
| Pneumonia | 286 (34.6) | 157 (30.5) | 1.31 (0.63-2.76) |
| Intra-abdominal | 108 (13.1) | 69 (13.4) | 1.13 (0.52-2.45) |
| Urinary tract infection | 174 (21.1) | 110 (21.4) | 1.14 (0.54-2.42) |
| Skin or soft tissue | 52 (6.3) | 44 (8.5) | 0.85 (0.38-1.93) |
| Central nervous system | 8 (1.0) | 2 (0.4) | 2.89 (0.52-15.90) |
| Endocarditis | 5 (0.6) | 2 (0.4) | 1.81 (0.30-10.79) |
| Catheter related | 19 (2.3) | 19 (3.7) | 0.72 (0.28-1.88) |
| Unknown Source | 107 (13.0) | 63 (12.2) | 1.23 (0.56-2.67) |
| Other | 49 (5.9) | 36 (7.0) | 0.98 (0.43-2.26) |
| No infection | 286 (34.6) | 157 (30.5) | Ref |
| Pre-randomization | |||
| Intravenous fluids (ml) | 2,223±51*** | 2,127±59 | P=0.30 |
| Fluids per body weight (ml/kg) | 29.7±22.0 | 27.9±19.1 | P=0.11 |
| Vasopressor use | 162 (19.6) | 66 (12.8) | 1.66 (1.22-2.26) |
| Dobutamine Use | 0 (0) | 0 (0) | -- |
| Blood Transfusion | 15 (1.8) | 6 (1.2) | 1.60 (0.60-4.07) |
| Mechanical Ventilation | 170 (20.6) | 18 (3.5) | 7.16 (4.34-11.79) |
| Intravenous Antibiotics | 611 (74.0) | 411 (79.8) | 0.72 (0.55-0.94) |
| Corticosteroids | 82 (9.9) | 39 (7.6) | 1.34 (0.90-2.00) |
| Activated Protein C | 0 (0) | 0 (0) | -- |
*
Four (4) participants in the non-EMS group received intravenous fluids prior to ED arrival.
**
Includes subjects transferred from another hospital facility.
***
Includes prehospital intravenous fluids
†
Includes only n=236 EMS patients who received intravenous fluids.