Table 4.
Subgroup analysis results for patients with septic shock
| Outcomes | HD group (n = 25) |
LD group (n = 28) |
RR or HR (95% CI) |
RD (95% CI) | p value |
|---|---|---|---|---|---|
| 14-day response, % | 48.0 (12/25) | 50.0 (14/28) | 0.960 (0.553, 1.666) | − 2.0 (− 27.0, 23.4) | 0.884 |
| Mortality | |||||
| 14-day mortality, % | 24.0 (6/25) | 32.1 (9/28) | 0.747 (0.309, 1.802) | − 8.1 (− 30.5, 15.9) | 0.511 |
| 28-day mortality, % | 40.0 (10/25) | 53.6 (15/28) | 0.747 (0.413, 1.348) | − 13.6 (− 37.3, 12.6) | 0.323 |
| Bacterial Clearance* | |||||
| Microbiological cure, % | 34.8 (8/23) | 32.0 (8/25) | 1.087 (0.489, 2.419) | − 2.8 (22.5, − 27.9) | 0.838 |
| Bacterial persistence, % | 65.2 (15/23) | 52.0 (13/25) | 1.254 (0.776, 2.028) | 13.2 (− 13.9, 37.7) | 0.354 |
| Superinfection, % | 8.7 (2/23) | 16.0 (4/25) | 0.544 (0.110, 2.692) | − 7.3 (− 27.0, 13.2) | 0.445 |
| Time-to-event data | |||||
| VFD#, Q2(Q1, Q3) | 10 (0, 22) | 14 (8, 18) | 0.947 (0.536, 1.674) | Not Applicable | 0.798 |
| ICU-days†, Q2(Q1, Q3) | 23 (15, 35) | 22 (12, 26) | 0.726 (0.416, 1.267) | Not Applicable | 0.271 |
| Hospital-days‡, Q2(Q1, Q3) | 28 (20, 39) | 28 (16, 46) | 1.112 (0.640, 1.930) | Not Applicable | 0.725 |
| OS, Q2(Q1, Q3) | 31 (17, 60) | 25 (10, 48) | 0.768 (0.434, 1.359) | Not Applicable | 0.369 |
| ssAUC0–24 at the seventh dose | |||||
| 50–100 mg · h/L, % | 71.4 (15/21) | 58.3 (14/24) | 1.225 (0.794, 1.888) | 13.1 (− 14.4, 37.6) | 0.360 |
| > 100 mg · h/L, % | 14.3 (3/21) | 0.0 (0/24) | Not Applicable | 14.3 (− 2.4, 34.6) | 0.055 |
| Adverse events | |||||
| AE, % | 52.0 (13/25) | 50.0 (14/28) | 1.04 (0.613, 1.764) | 2.0 (− 23.4, 27.0) | 0.884 |
| AKI, % | 16.0 (4/25) | 21.4 (6/28) | 0.747 (0.238, 2.345) | − 5.4 (− 25.9, 16.3) | 0.614 |
| KIDGO Stage 1 | 50.0 (2/4) | 50.0 (3/6) | 1.000 (0.282, 3.544) | 0.0 (46.9, 46.9) | 1.000 |
| KIDGO Stage 2 | 25.0 (1/4) | 33.3 (2/6) | 0.750 (0.098, 5.768) | − 8.3 (− 50.3, 42.5) | 1.000 |
| KIDGO Stage 3 | 25.0 (1/4) | 16.7 (1/6) | 1.500 (0.127, 17.667) | 8.3 (−36.3, 55.3) | 1.000 |
Data are n (%) or median (IQR). n: sample size. HD: high dose. LD: low dose. RR: relative risk. HR: hazard ratio. RD: Risk Difference. *: Superinfection and original Bacterial persistence co-exist in 2 patients, so the sum of the parts of bacterial clearance is greater than 100% #: Ventilated-free days at 28 days. †: Length of ICU stay. ‡: Length of hospital stay. OS: overall survival. AE: adverse events. AKI: acute kidney injury. KDIGO: Kidney Disease Improving Global Outcomes