Introduction
Material and methods
Study design
Study population
Data collection
Statistical analysis
Results
Characteristic | Physician diagnosis | Both criteria | Consensus criteria |
p value* |
---|---|---|---|---|
N | 137 | 301 | 266 | |
Age (yr) | 1 (0.5–7) | 3 (0.7–10) | 3 (0.7–11) | 0.03 |
Sex, n (%) | 0.74 | |||
Male | 76 (55) | 164 (55) | 138 (52) | |
Female | 61 (45) | 137 (45) | 128 (48) | |
Comorbid conditions, n (%) | ||||
Respiratory | 54 (39) | 73 (24) | 99 (37) | 0.001 |
Gastrointestinal | 40 (29) | 62 (21) | 79 (30) | 0.03 |
Cardiovascular | 34 (25) | 62 (21) | 74 (28) | 0.13 |
Genetic | 35 (26) | 54 (18) | 61 (23) | 0.14 |
Hematologic/immunologic | 28 (20) | 69 (23) | 45 (17) | 0.21 |
Neuromuscular | 11 (8) | 37 (12) | 60 (23) | <0.001 |
Neoplastic | 18 (13) | 51 (17) | 29 (11) | 0.11 |
Prematurity | 37 (12) | 24 (18) | 39 (15) | 0.35 |
Metabolic | 17 (12) | 28 (9) | 34 (13) | 0.38 |
Renal | 15 (11) | 24 (8) | 31 (12) | 0.31 |
Solid organ/stem cell transplant | 8 (6) | 28 (9) | 26 (10) | 0.39 |
Comorbid conditions, n (%) | <0.001 | |||
None | 30 (22) | 85 (28) | 43 (16) | |
1 | 21 (15) | 77 (26) | 64 (24) | |
≥ 2 | 86 (63) | 21 (15) | 159 (60) | |
Admission POPC, n (%) | 0.13 | |||
Good performance | 70 (51) | 170 (56) | 120 (45) | |
Mild disability | 26 (19) | 44 (15) | 41 (15) | |
Moderate disability | 22 (16) | 44 (15) | 46 (17) | |
Severe disability or coma | 19 (14) | 43 (14) | 59 (22) | |
PIM-3 scorea
| 3.6 (1.4–5.5) | 4.4 (1.9–9.2) | 4.3 (1.8–9.9) | <0.001 |
PELOD scoreb
| 10 (1–11) | 11 (2–13) | 11 (2–12) | <0.001 |
Source of admission, n (%) | 0.86 | |||
Emergency departmentc
| 41 (30) | 89 (30) | 78 (29) | |
Hospital floor | 39 (29) | 92 (31) | 66 (25) | |
Operating room | 12 (9) | 28 (9) | 22 (8) | |
Other hospitald
| 39 (28) | 77 (26) | 89 (33) | |
Organ dysfunction at sepsis recognitione
| ||||
Cardiovascular | 51 (37) | 182 (61) | 106 (40) | <0.001 |
Respiratory | 88 (64) | 211 (70) | 197 (74) | 0.12 |
Renal | 5 (4) | 19 (6) | 7 (3) | 0.10 |
Hepatic | 2 (1) | 16 (5) | 6 (2) | 0.07 |
Hematologic | 4 (3) | 49 (16) | 24 (9) | <0.001 |
Neurologic | 9 (7) | 28 (9) | 33 (12) | 0.17 |
Primary site of infection, n (%) | ||||
Respiratory | 60 (44) | 101 (34) | 127 (48) | 0.002 |
Primary bloodstream | 25 (18) | 82 (27) | 26 (10) | <0.001 |
Abdominal | 15 (11) | 31 (10) | 16 (6) | 0.11 |
Central nervous system | 3 (2) | 9 (3) | 16 (6) | 0.11 |
Genitourinary | 7 (5) | 12 (4) | 9 (3) | 0.67 |
Skin | 4 (3) | 16 (5) | 4 (2) | 0.04 |
Other | 6 (4) | 16 (5) | 13 (5) | 0.95 |
Unknown | 17 (12) | 34 (11) | 55 (21) | 0.006 |
Microbiology,f,g n (%) | ||||
Gram-positive bacteria | 39 (28) | 90 (30) | 60 (23) | 0.13 |
Gram-negative bacteria | 27 (20) | 95 (32) | 63 (24) | 0.02 |
Fungus | 9 (7) | 39 (13) | 37 (14) | 0.07 |
Virus | 35 (26) | 50 (17) | 69 (26) | 0.01 |
No organism identified | 50 (36) | 95 (32) | 101 (38) | 0.25 |
Laboratory examination | Physician diagnosis | Both criteria | Consensus criteria |
p value* | |||
---|---|---|---|---|---|---|---|
Percenta
| Median (IQR) | Percenta
| Median (IQR) | Percenta
| Median (IQR) | ||
WBC, max (103/μl) | 92 % | 10.1 (7.3–16.6) | 97 % | 14.9 (7.5–22.7) | 91 % | 14.6 (8.8–20.8) | <0.001 |
Platelets, min (103/μl) | 91 % | 148 (70–262) | 96 % | 95 (39–195) | 89 % | 157 (77–287) | <0.001 |
BUN, max (mg/dl) | 83 % | 13 (8–22) | 93 % | 21 (12–41) | 92 % | 18 (10–31) | <0.001 |
Creatinine, max (mg/dl) | 92 % | 0.4 (0.3–0.6) | 97 % | 0.5 (0.3–0.9) | 97 % | 0.4 (0.3–0.7) | <0.001 |
ALT, max (IU/L) | 55 % | 39 (25–67) | 77 % | 53 (28–123) | 62 % | 50 (26–110) | 0.09 |
Total bilirubin, max (mg/dl) | 53 % | 0.7 (0.4–1.7) | 73 % | 1.0 (0.5–2.9) | 59 % | 0.7 (0.4–3.0) | 0.02 |
Albumin, min (g/dl) | 66 % | 2.6 (2.2–3.0) | 81 % | 2.5 (2.2–3.0) | 71 % | 2.8 (2.3–3.3) | <0.001 |
INR, max | 37 % | 1.3 (1.2–1.7) | 64 % | 1.3 (1.2–1.8) | 42 % | 1.3 (1.1–1.8) | 0.80 |
Lactate, max (mmol/L) | 62 % | 1.4 (1.1–2.0) | 75 % | 2.0 (1.2–3.8) | 62 % | 1.6 (1.1–2.8) | 0.001 |
ScvO2, min (%) | 28 % | 70 (57–75) | 46 % | 65 (52–74) | 30 % | 65 (49–73) | 0.50 |
PaO2/FiO2 ratio, min (mmHg) | 47 % | 138 (89–233) | 72 % | 160 (100–236) | 51 % | 144 (87–275) | 0.79 |
C-reactive peptide, max (mg/dl) | 39 % | 7.1 (2.1–17.8) | 64 % | 9.3 (2.8–20.8) | 43 % | 3.8 (1.6–9.7) | <0.001 |
Procalcitonin, max (ng/ml) | 12 % | 3.5 (1.1–11.6) | 22 % | 6.4 (1.4–23.0) | 6 % | 1.3 (0.24–5.4) | 0.01 |
Therapy | Physician diagnosis | Both criteria | Consensus criteria |
p value* |
---|---|---|---|---|
Vasoactive infusionsa
| 53 (39) | 209 (69) | 105 (39) | <0.001 |
Invasive mechanical ventilation | 92 (67) | 229 (76) | 192 (72) | 0.14 |
Corticosteroids | 46 (36) | 132 (44) | 110 (41) | 0.13 |
Albumin | 24 (18) | 90 (30) | 45 (17) | <0.001 |
Blood productsb
| 39 (28) | 159 (53) | 73 (27) | <0.001 |
Insulinc
| 4 (3) | 32 (11) | 25 (9) | 0.02 |
G/GM-CSF | 2 (1) | 17 (6) | 6 (2) | 0.04 |
IVIG | 7 (5) | 28 (9) | 10 (4) | 0.02 |
RRTd
| 13 (9) | 57 (19) | 24 (9) | 0.001 |
Plasma exchange | 1 (1) | 3 (1) | 2 (1) | 0.94 |
ECMO | 3 (2) | 14 (5) | 16 (6) | 0.23 |
Outcome | Physician diagnosis | Both criteria | Consensus criteria |
p value* |
---|---|---|---|---|
Vasoactive-free days, median (IQR) | 27 (22–28) | 22 (6–26) | 26 (17–28) | <0.001 |
Ventilator-free days, median (IQR) | 19 (2–27) | 16 (0–24) | 18 (0–26) | 0.07 |
NPMODSa
| 47 (34) | 131 (44) | 97 (36) | 0.10 |
PICU mortality | 23 (17) | 82 (27) | 57 (21) | 0.042 |
At least mild disabilityb
| 24 (22) | 67 (31) | 50 (24) | 0.15 |
At least moderate disabilityc
| 14 (13) | 36 (17) | 37 (18) | 0.46 |
Variable | Adjusted ORa
| 95 % confidence interval |
p value |
---|---|---|---|
Severe sepsis definition | |||
Both criteria | Reference | ||
Physician diagnosis, only | 0.64 | 0.37–1.11 | 0.12 |
Consensus criteria, only | 0.73 | 0.48–1.12 | 0.15 |
Age, yr | 0.99 | 0.95–1.02 | 0.45 |
PIM-3 score | 1.04 | 1.03–1.06 | <0.001 |
Comorbid conditions | |||
None | Reference | ||
1 comorbid condition | 1.11 | 0.62–2.01 | 0.72 |
≥2 comorbid conditions | 1.78 | 1.07–2.99 | 0.03 |
Developed regionb
| 0.63 | 0.37–1.06 | 0.08 |
Discussion
Conclusions
Key messages
-
Although consensus criteria for pediatric sepsis were established to facilitate consistent enrollment across research studies, the extent to which these criteria reflect physician diagnosis of severe sepsis, which underlies external validity for pediatric sepsis research, is not known.
-
Of 6925 PICU patients screened at 128 PICUs in 26 countries, 706 patients were identified by physician diagnosis and/or consensus criteria as having severe sepsis.
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Only 301 patients (42.6 %) were identified by both physician diagnosis and consensus criteria (κ 0.57 ± 0.02).
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The 31 % of patients with physician-diagnosed severe sepsis who did not meet consensus criteria were younger, had a lower severity of illness, and a lower PICU mortality than those who met consensus criteria or both definitions.
-
The results of a research study based on consensus criteria may have limited generalizability to nearly one-third of PICU patients diagnosed with severe sepsis.