|
Category
|
AEs and concomitant treatments
|
Total N (%)
|
CPC 1 and 2 n (%)
|
CPC 3–5 n (%)
|
OR (95 % CI)
|
p
|
Adjusted OR (95 % CI)
|
p
|
|---|
| | |
704 (100)
|
228(32.4)
|
476 (67.6)
| | | | |
|
Cooling -related AEs
|
Overcoolinga
|
128 (18.2)
|
23 (10.1)
|
105 (22.1)
|
2.52 (1.56–4.09)
|
<.001
|
1.16 (0.58–2.31)
|
0.681
|
|
Bradycardiab
|
83 (11.8)
|
35 (15.4)
|
48 (10.1)
|
0.62 (0.39–0.99)
|
0.044
|
0.75 (0.37–1.53)
|
0.429
|
|
Tachyarrhythmia
|
67 (9.5)
|
24 (10.5)
|
43 (9.0)
|
0.84 (0.50–1.43)
|
0.528
|
0.72 (0.33–1.55)
|
0.398
|
|
Hypokalemiac
|
220 (31.3)
|
65 (28.5)
|
155 (32.6)
|
1.21 (0.86–1.71)
|
0.278
|
1.21 (0.71–2.04)
|
0.486
|
|
Hyperglycemiad
|
321 (45.6)
|
81 (35.5)
|
240 (50.4)
|
1.85 (1.33–2.56)
|
<.001
|
1.37 (0.84–2.24)
|
0.210
|
|
Bleeding
|
21 (3.0)
|
6 (2.6)
|
15 (3.2)
|
1.20 (0.46–3.15)
|
0.705
|
0.89 (0.21–3.71)
|
0.872
|
|
Hypotensione
|
204 (29.0)
|
54 (23.7)
|
150 (31.5)
|
1.48 (1.03–2.13)
|
0.033
|
1.03 (0.59–1.79)
|
0.926
|
|
Rewarming -related AEs
|
Rebound hyperthermiaf
|
85 (12.1)
|
29 (12.7)
|
56 (11.8)
|
0.92 (0.57–1.48)
|
0.716
|
1.33 (0.61–2.92)
|
0.473
|
|
Arrhythmia
|
42 (6.0)
|
10 (4.4)
|
32 (6.7)
|
1.57 (0.76–3.25)
|
0.224
|
1.70 (0.61–4.69)
|
0.308
|
|
Hyperkalemiag
|
48 (6.8)
|
7 (3.1)
|
41 (8.6)
|
2.96 (1.31–6.74)
|
0.009
|
1.09 (0.37–3.19)
|
0.881
|
|
Hypoglycemiah
|
70 (9.9)
|
22 (9.7)
|
48 (10.7)
|
1.05 (0.62–1.79)
|
0.858
|
1.14 (0.50–2.57)
|
0.762
|
|
Bleeding
|
14 (2.0)
|
3 (1.3)
|
11 (2.3)
|
1.77 (0.49–6.41)
|
0.383
|
1.05 (0.18–6.06)
|
0.956
|
|
Hypotensione
|
152 (21.6)
|
36 (15.8)
|
116 (24.4)
|
1.72 (1.14–2.60)
|
0.01
|
0.99 (0.54–1.83)
|
0.984
|
|
Other AEs during advanced critical care Concomitant treatments
|
Pneumoniai
|
279 (39.6)
|
70 (30.7)
|
209 (43.9)
|
1.77 (1.26–2.47)
|
<.001
|
1.05 (0.63–1.74)
|
0.852
|
|
Sepsis
|
100 (14.2)
|
17 (7.5)
|
83 (17.4)
|
2.62 (1.52–4.53)
|
<.001
|
3.12 (1.40–6.97)
|
0.005
|
|
Myoclonusj
|
154 (21.9)
|
34 (14.9)
|
120 (25.2)
|
1.92 (1.27–2.92)
|
0.002
|
3.72 (1.93–7.16)
|
<.001
|
|
Seizurek
|
153 (21.7)
|
24 (10.5)
|
129 (27.1)
|
3.16 (1.98–5.05)
|
<.001
|
4.02 (2.04–7.91)
|
<.001
|
|
Hypoglycemial
|
162 (23.0)
|
36 (15.8)
|
126 (26.5)
|
1.92 (1.27–2.89)
|
0.002
|
2.03 (1.09–3.78)
|
0.025
|
|
Anticonvulsants
|
287 (40.8)
|
71 (31.1)
|
216 (45.4)
|
1.84 (1.32–2.56)
|
<.001
|
1.69 (1.03–2.77)
|
0.039
|
|
Insulin
|
460 (65.3)
|
136(59.7)
|
324 (68.1)
|
1.44 (1.04–2.00)
|
0.028
|
0.98 (0.60–1.62)
|
0.944
|
|
Analgesics
|
323 (45.9)
|
122 (53.5)
|
201 (42.2)
|
0.64 (0.46–0.87)
|
0.005
|
0.75 (0.46–1.21)
|
0.239
|
|
Sedatives
|
657 (93.3)
|
222 (97.4)
|
435 (91.4)
|
0.29 (0.12–0.69)
|
0.005
|
0.92 (0.29–2.96)
|
0.888
|
|
Neuromuscular blockers
|
475 (67.5)
|
174 (76.3)
|
301 (63.2)
|
0.53 (0.37–0.76)
|
0.001
|
0.48 (0.28–0.84)
|
0.009
|
-
AEs adverse events, CPC cerebral performance category, OR odds ratio, 95 % CI 95 % confidence interval
-
a < 32 °C
-
bHeart rate <40 bpm
-
c ≤ 3.0 mEq/L
-
d ≥ 180 mg/Dl
-
eSBP <90 mmHg or MAP <60 mmHg for at least 30 min or the need for supportive measures (fluid loading and vasopressors or inotropic or both) to maintain a SBP >90 mmHg or MAP >60 mmHg
-
f > 38 °C within 24 hours of the cessation of cooling
-
g ≥ 5.0 mEq/L
-
h ≤ 80 mg/dL
-
iFour requirements: 1) new or progressive consolidation on the chest radiograph, 2) fever, 3) leukocytosis, and 4) the presence of purulent tracheobronchial secretions
-
jClinically involuntary movement without epileptiform discharge on EEG
-
kEither clinically involuntary movement with epileptiform discharge on electroencephalogram (EEG) or epileptiform discharge only on EEG
-
l ≤ 80 mg/dL within 72 hours after ROSC
