Table 2.
Treatments administered and adverse events
| SSSP n=53 |
Control n=56 |
p | |
|---|---|---|---|
| Initial antibiotic regimens a | -- | ||
| 3rd gen cephalosporin b | 22 (41.5) | 20 (35.7) | |
| 3rd gen cephalosporin combination c | 5 (9.4) | 10 (17.9) | |
| Penicillin G | 4 (7.5) | 4 (7.2) | |
| Penicillin G + chloramphenicol | 6 (11.3)d | 7 (12.5) | |
| Other Penicillin G combination c | 6 (11.3) | 3 (5.4) | |
| Ciprofloxacin +/− metronidazole | 5 (9.4) | 3 (5.4) | |
| Other e | 4 (7.5) | 7 (12.5) | |
| Not documented | 1 (1.9) | 2 (3.6) | |
|
| |||
| Co-trimoxazole f | 6 (11.3) | 8 (14.3) | 0.64 |
|
| |||
| Antituberculous therapy | 0.087 | ||
| Started at admission or before | 8 (15.1) | 9 (16.1) | |
| Started after admission | 13 (24.5) | 5 (8.9) | |
|
| |||
| Median time to antibiotics, hrs (IQR) g | |||
| from admission | 1.5 (0.5-3.7) | 1.3 (0.4-3.0) | 0.42 |
| from study enrollment | −0.7 (−2.5-0.5) | 0 (−1.5-0.9) | 0.19 |
|
| |||
| Received ≥3L fluid in 6 hours, n (%) | 30 (56.6) | 11 (20.0) | <0.001 |
|
| |||
| Fluids administered, L, mean (SD) h | |||
| In first 6 hours | 2.9 (1.0) | 1.6 (1.1) | <0.001 |
| In first 24 hours | 3.9 (1.3) | 3.0 (2.1) | 0.02 |
| In first 72 hours | 5.6 (2.3) | 4.3 (2.9) | 0.02 |
|
| |||
| Received blood transfusion, n (%) | 16 (30.2) | 11 (19.6) | 0.20 |
|
| |||
| Median time to transfusion, hrs (IQR) g | 16.0 (7.3-32.9) | 5.5 (0-13.8) | 0.17 |
|
| |||
| Received dopamine, n (%) | 1 (1.8) | 3 (5.7) | 0.28 |
|
| |||
| Stopped IV fluids early, n (%) | 25 (49.0) | -- | -- |
|
| |||
| Reasons for stopping: | |||
| Raised JVP | 7 (13.2) | ||
| Respiratory changes | 8 (15.1) | ||
| Lost IV access | 2 (3.8) | ||
| Transfuse blood | 5 (9.4) | ||
| Oliguria | 1 (1.9) | ||
| Other | 2 (3.8) | ||
|
| |||
|
Increase in RR or decrease in SpO2 in
first 6 hours, n (%) i |
18 (34.0) | 16 (28.6) | 0.54 |
Excludes anti-tuberculous therapy or co-trimoxazole therapy, listed separately
Includes 3 patients who received 3rd gen cephalosporin plus crystalline penicillin
Includes combinations with ciprofloxacin, erythromycin, metronidazole, and/or cloxacillin
Includes 2 patients who received Crystalline penicillin + chloramphenicol + metronidazole
Cloxacillin+metronidazole (1), chloramphenicol (1), erythromycin (3), cotrimoxazole mono-threrapy (2), antituberculous therapy only (4)
Includes prophylaxis or treatment doses, used with one of the above combinations in 12 patients; 2 patients received only co-trimoxazole
Missing data on time to blood transfusion in 2 transfused patients and antibiotics start time in 12 patients
Missing data for fluids in first 6 hours (1 patient), 24 hours (8 patients), and 72 hours (15 patients)
Respiratory changes included respiratory rate increase of 5 breaths/min or more or decrease in oxyhemoglobin saturation of 3% or more
SSSP=Simplified Severe Sepsis Protocol, IQR=Interquartile range, SD=Standard deviation, L=Liters, JVP=Jugular venous pressure, IV=Intravenous