Background
Methods
Study population
Randomization
Study treatments
Endotoxin activity assay
Measurement of mHLA-DR expression, CD11b expression on neutrophils, and neutrophil chemotaxis
Neutrophil isolation
Flow cytometry for detecting mHLA-DR expression and CD11b expression on neutrophils
Neutrophil chemotaxis
Measurement of presepsin
Data collection
Outcomes
Statistical analysis
Results
Cohort characteristics
Characteristic | PMX-HP group (n = 29) | Non-PMX-HP group (n = 30) | P valuea |
---|---|---|---|
Age (years), mean (SD) | 70.2 (13.0) | 67.4 (14.6) | 0.43 |
Male, n (%) | 23 (79) | 17 (57) | 0.06 |
BMI (kg/m2), mean (SD) | 24.2 (4.3) | 23.5 (4.7) | 0.62 |
Baseline serum creatinine (mg/dl), median (Q1, Q3) | 1.0 (1.0, 1.1) | 1.0 (0.8, 1.1) | 0.48 |
BUN at enrollment (mg/dl), median (Q1, Q3) | 41 (26, 63) | 41 (22, 62) | 0.65 |
Serum creatinine at enrollment (mg/dl), median (Q1, Q3) | 2.2 (1.6, 3.1) | 2.6 (1.8, 4.0) | 0.34 |
AKI, n (%) | 0.16 | ||
Non-AKI | 4 (14) | 5 (17) | |
Stage 1 | 8 (28) | 4 (13) | |
Stage 2 | 9 (31) | 5 (17) | |
Stage 3 | 8 (28) | 16 (53) | |
RRT, n (%) | 27 (93) | 20 (69) |
0.02
|
CRRT | 21 (72%) | 14 (48%) | |
SLED | 6 (21%) | 4 (14%) | |
Peritoneal dialysis | 0 (0%) | 2 (7%) | |
SOFA score, mean (SD) | 13.8 (4.4) | 13.3 (5.0) | 0.71 |
Type of fluid, n (%) | |||
Crystalloid | 23 (79) | 23 (77) | 0.81 |
Colloid | 15 (52) | 13 (43) | 0.52 |
Inotrope/vasopressor use, n (%) | 25 (86) | 25 (83) | > 0.99 |
Adrenaline | 8 (28) | 6 (20) | 0.49 |
Noreadrenaline | 20 (69) | 22 (73) | 0.71 |
Dopamine | 8 (28) | 4 (13) | 0.17 |
Dobutamine | 4 (14) | 3 (10) | 0.71 |
Vasopressin | 0 (0) | 0 (0) | > 0.99 |
Terlipressin | 1 (3) | 0 (0) | 0.49 |
Inotropic score (μg/kg/min), median (Q1, Q3) | 36 (7, 70) | 30 (2, 83) | 0.96 |
Vasopressor index (μg/kg/min/mmHg), median (Q1, Q3) | 0.4 (0.1, 1.1) | 0.4 (0.1, 1.1) | 0.93 |
EAA at enrollment, median (Q1, Q3) | 0.8 (0.7, 1.0) | 0.7 (0.7, 0.9) | 0.24 |
Presepsin (pg/ml), median (Q1, Q3) | 5514 (4088, 10,513) | 5030 (2459, 10,734) | 0.47 |
Characteristic | PMX-HP group (n = 29) | Non PMX-HP group (n = 30) | Overall (N = 59) | P valuea |
---|---|---|---|---|
Organism | ||||
Gram-positive bacteria | 7 (23%) | 2 (7%) | 9 (15%) | 0.15 |
Gram-negative bacteria | 13 (43%) | 18 (60%) | 31 (53%) | 0.20 |
Fungal infection | 1 (3%) | 2 (7%) | 3 (5%) | 1.00 |
Mycobacterium | 1 (3%) | 0 (0%) | 1 (2%) | 1.00 |
Other | 0 (0%) | 1 (3%) | 1 (2%) | 1.00 |
Site of infection | ||||
Central nervous system | 2 | 0 | 2 (3%) | 0.14 |
Respiratory tract | 6 | 12 | 18 (31%) | 0.11 |
Gastrointestinal tract | 9 | 6 | 15 (25%) | 0.33 |
Genitourinary tract | 3 | 3 | 6 (10%) | 0.97 |
Musculoskeletal | 0 | 3 | 3 (5%) | 0.08 |
Systemic infection | 5 | 4 | 9 (15%) | 0.68 |
Other | 5 | 3 | 8 (14%) | 0.42 |
Primary outcome
Outcome | PMX-HP group | Non-PMX-HP group | ||||||
---|---|---|---|---|---|---|---|---|
Baseline (n = 29) | Day 3 (n = 26) | P value within groupa | Baseline (n = 30) | Day 3 (n = 20) | P value within groupb | P value between groups on day 3c | P value between group change from baseline and day 3d | |
Primary outcome | ||||||||
mHLA-DR expression (%), median (Q1, Q3) | 33.4 (27.4–40.7) | 39.2 (27.1–45.8) |
0.025
e
| 30 (15.8–36.6) | 30.7 (19.5–36.8) | 0.13 |
0.027 (0.042)
e
| 0.027 (0.11)e |
mHLA-DR expression (MFI), mean (SD) | 481.4 (131.5) | 509.0 (139.9) | 0.78 | 446.6 (142.1) | 447.3 (148.9) | 0.35 | 0.16 (0.035)e | 0.34 (0.038)e |
Secondary outcomes | ||||||||
CD11b (%), mean (SD) | 15.4 (9) | 13.7 (9.5) | 0.30 | 14.3 (10.5) | 16.2 (10.1) |
0.001
| 0.39 (0.15)e |
0.002 (0.001)
e
|
CD-11b (MFI), mean (SD) | 189.7 (57.1) | 165.4 (53.1) |
0.045
| 186.2 (53.3) | 223.5 (48.0) |
< 0.001
|
0.001 (< 0.001)
e
|
< 0.001 (< 0.001)
e
|
Neutrophil chemotaxis (%), mean (SD) | 42.8 (12.5) | 47.9 (10.2) |
0.030
| 42.3 (13.7) | 46.2 (12.3) | 0.74 | 0.60 (0.77)e | 0.07 (0.08)e |
Presepsin (pg/ml), median (Q1, Q3) | 5514 (4088, 10,513) | 2895 (2190, 6038) | 0.059 | 5030 (2459, 10,734) | 3468 (2204, 6038) | 0.12 | 0.93 | 0.38 |
CVS SOFA score, median (Q1, Q3) | 4 (4, 4) | 3 (0, 4) |
0.003
| 4 (4, 4) | 3 (1, 4) | 0.26 | 0.71 | 0.16 |
Inotropic score, median (Q1, Q3) | 36 (6.6, 70) | 11 (1, 49.2) | 0.13 | 30 (2, 83) | 14 (0, 36) | 0.94 | 0.57 | 0.20 |
Vasopressor dependency index (mmHg−1), median (Q1, Q3) | 0.4 (0.1, 1.1) | 0.1 (0.01, 0.7) | 0.14 | 0.4 (0.1, 1.1) | 0.2 (0, 0.6) | 0.96 | 0.60 | 0.25 |
Noradrenaline (μg/kg/min), median (Q1, Q3) | 0.2 (0.0, 0.4) | 0.01 (0, 0.2) | 0.23 | 0.3 (0.0, 0.4) | 0.1 (0, 0.4) | 0.85 | 0.42 | 0.42 |
EAA level, median (Q1, Q3) | 0.8 (0.7, 1) | 0.7 (0.6, 0.9) | 0.11 | 0.7 (0.7, 0.9) | 0.6 (0.5, 0.9) | 0.14 | 0.84 | 0.90 |
Secondary outcomes
PMX-HP group | Non PMX-HP group | P valuea | |
---|---|---|---|
Overall | n = 29 | n = 30 | |
Mortality on day 3, n (%) | 3 (10.3) | 10 (33.3) | 0.058 |
Mortality on day 7, n (%) | 6 (20.7) | 12 (40.0) | 0.11 |
Mortality on day 28, n (%) | 17 (58.6) | 15 (50.0) | 0.51 |
MAKE 28b (%) | 22 (75.9) | 22 (73.3) | 1.00 |
Alive on day 28 | n=13c | n = 15 | |
ICU-free days (Q1, Q3) | 0 (0, 10) | 0 (0, 8) | 0.99 |
Ventilator-free days (Q1, Q3) | 0 (0, 8) | 0 (0, 0) | 0.28 |
RRT, n (%) | 7 (53.8) | 6d (50.0) | 0.85 |
Serum creatinine (mg/dl) (Q1, Q3) | 1.4 (1.1, 2.2) | 2.1 (1.3, 2.5) | 0.59 |
Vasopressor free days (Q1, Q3) | 0 (0, 25) | 11.5 (0, 25) | 0.47 |
AKI at baseline | n = 25 | n = 25 | |
Renal recoverye, n (%) | 5 (20.0) | 3 (12.0) | 0.70 |