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Table 1 Baseline characteristics of patients enrolled in the INCLASS study

From: Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial

 

Clarithromycin (n = 55)

Placebo (n = 55)

Total (n= 110)

P value

Age (years), median (Q1–Q3)

74 (67–80)

73 (60–79)

74 (62–80)

0.354

Sex, n (%)

   

0.316

 Male

39 (70.9)

33 (60.0)

72 (65.5)

 

 Female

16 (29.1)

22 (40.0)

38 (34.5)

 

Charlson comorbidity index, mean (SD)

5.3 (2.8)

5.6 (2.8)

5.4 (2.8)

0.496

APACHE II score, mean (SD)

20.0 (6.4)

22.0 (7.1)

21.0 (6.8)

0.193

SOFA score, median (Q1-Q3)

10 (9–12)

11 (9–13)

10 (9–12)

0.364

Presence of ARDS, n (%)

23 (41.8)

25 (45.5)

48 (43.6)

0.848

Presence of septic shock, n (%)

30 (54.5)

39 (70.9)

69 (62.7)

0.114

Laboratory values, median (Q1-Q3)

    

 Lactate, mmol/l

1.8 (1.4–2.6)

2.1 (1.4–3.0)

2.0 (1.4–2.8)

0.459

 PaO2/FiO2

142 (111–171)

149 (116–167)

144 (114–165)

0.886

 White blood cell count, × 103/mm3

15.9 (10.8–20.8)

16.7 (10.9–21.4)

16.2 (10.9–20.9)

0.832

 Platelet count, × 103/mm3

130 (196–264)

197 (138–278)

197 (137–268)

0.907

 Creatinine, mg/dl

1.80 (1.05–2.41)

1.40 (0.80–2.40)

1.60 (0.87–2.4)

0.140

 CRP, mg/l

169.0 (91.5–259.4)

158.0 (66.2–233.8)

162.9 (81.7–254.8)

0.543

 PCT, ng/ml

1.42 (0.48–9.54)

1.36 (0.55–5.43)

1.42 (0.55–5.71)

0.900

Organ support at enrollment

    

 Mechanical Ventilation, n (%)

45 (81.8)

44 (80.0)

89 (80.9)

1.00

 PEEPa, median (Q1-Q3)

8 (6–10)

8 (7–10)

8 (6–10)

0.524

 Tidal Volumea, median (Q1-Q3)

502 (460–550)

500 (450–550)

500 (455–550)

0.638

 Noradrenaline use, n (%)

54 (98.2)

55 (100.0)

99 (90.0)

1.00

 Renal Replacement Therapy, n (%)

8 (14.5)

9 (16.4)

17 (15.5)

1.00

Source of sepsis, n (%)

    

 Lower respiratory tract infection

34 (61.8)

41 (74.5)

75 (68.2)

0.219

 Healthcare-associated

12 (21.8)

11 (20.0)

23 (20.9)

1.00

 Hospital-acquired

6 (10.9)

15 (27.3)

21 (19.1)

0.051

 Ventilator-associated

16 (29.1)

15 (27.3)

31 (28.2)

1.00

Intra-abdominal infection

15 (27.3)

12 (21.8)

27 (24.5)

0.658

Primary Gram-negative bacteremia

6 (10.9)

2 (3.6)

8 (7.3)

0.271

  1. SI conversion factors: To convert white blood cell count to 109/L, multiply by 1; platelet count to 109/L, multiply by 1; and (serum) creatinine to μmol/L, multiply by 88.4
  2. APACHE, Acute Pathophysiology and Chronic Health Evaluation; ARDS, acute respiratory distress syndrome; CRP, C-reactive protein; PCT, procalcitonin; PEEP, positive end-expiratory pressure; SD, standard deviation; and SOFA, Sequential Organ Failure Assessment
  3. aRefers to patients under mechanical ventilation
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