Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial

Table 1 Baseline characteristics

Characteristics	Hydrocortisone (n = 98)	Placebo (n = 99)	p Value^a
Age, years	64.5 ± 17.3	64.3 ± 16.0	0.76
Male sex, n (%)	50 (51)	51 (51.5)	1.0
APACHE II score^b	21.7 ± 5.7	21.9 ± 5.7	0.79
SOFA score^c	10.9 ± 3.5	10.8 ± 3.6	0.91
Lung Injury Score,^d mean ± SE	2.2 ± 0.9	2.2 ± 1.0	0.7
Vasopressor-dependent shock, n (%)	78 (79.6)	76 (76.8)	0.55
Lactate, mmol/L	3.9 ± 2.2	4.0 ± 2.5	0.95
Lactate >2 mmol/L, n (%)	85 (86.7)	82 (82.7)	0.55
Mild ARDS: PaO₂/FiO₂ 201–300,^e n (%)	32 (32.7)	33 (33.7)	1.0
Moderate ARDS: PaO₂/FiO₂ 101–200,^e n (%)	54 (55.1)	48 (48)	0.39
Severe ARDS: PaO₂/FiO₂ ≤ 100,^e n (%)	12 (12.2)	18 (18.4)	0.32
Tidal volume, ml/kg of predicted body weight	7.06 ± 1.12	7.57 ± 1.34	0.04
Tidal volume >8 ml/kg of predicted body weight, n (%)	35 (35.4)	41 (41.8)	0.38
Positive end-expiratory pressure, cmH₂O	7.3 ± 3.0	6.8 ± 2.5	0.59
PaO₂/FiO₂, mmHg, mean ± SE	175.4 ± 6.9	172.4 ± 6.7	0.87
Source of infection, n (%)
Pneumonia	49 (50)	51 (52)	0.89
Urinary tract infection	18 (18.4)	19 (19.2)	1.0
Skin and soft tissue infection	15 (15.3)	12 (12.1)	0.54
Intra-abdominal infection	15 (15.3)	7 (7.1)	0.07
Hemoculture-positive	28 (28.6)	28 (28.3)	1.0
Number of comorbidities, median (range)	2 (0–5)	2 (0–5)	1.0
Hypertension	44 (44.9)	43 (43.4)	0.89
Diabetes mellitus	45 (45.9)	37 (37.4)	0.25
Coronary artery disease	18 (18.4)	17 (17.2)	0.85
Stroke	21 (21.4)	14 (14.1)	0.2
Chronic kidney disease	12 (12.2)	12 (12.1)	1.0
Chronic lung disease	11 (11.2)	11 (11.1)	1.0
Cancer and/or immunosuppression	18 (18.4)	26 (26.3)	0.23

Abbreviations: APACHE II Acute Physiology and Chronic Health Evaluation II, ARDS Acute respiratory distress syndrome, FiO ₂ Fraction of inspired oxygen, PaO ₂ Partial pressure of oxygen in arterial blood, SOFA Sequential Organ Failure Assessment
Unless specified otherwise, data are reported as mean ± SD
^aFisher’s exact test and the Wilcoxon-Mann-Whitney test were used for categorical and continuous variables, respectively
^bAPACHE II score, a severity-determining score, ranges from 0 to 71. The higher scores represent more severe disease
^cSOFA score ranges from 0 to 24. The higher scores represent more organ failure
^dThe Lung Injury Score ranges from 0 to 4. Scores of 0.1–2.5 indicate mild to moderate lung injury; scores >2.5 indicate severe lung injury
^eDiagnosis of ARDS according to the Berlin Definition 2012

ISSN: 1364-8535