Table 5 |
|||
|
Summary of outcomes and complications |
|||
|
Parameters |
Vigileo group |
Control group |
P value |
|
|
|||
|
Number of patients |
|||
|
ITT analysis |
60 |
60 |
|
|
Per protocol analysis |
51 |
54 |
|
|
|
|||
|
Mortality (%) |
|||
|
ITT |
1 (1.67%) |
2 (3.33%) |
1.0 |
|
Per protocol |
1 (1.96%) |
1 (1.85%) |
0.501 |
|
Hospital length of stay (days) |
|||
|
ITT |
9 (8-11.5) |
10 (8-16) |
0.0937 |
|
Per protocol |
9 (8-12) |
10(8-19) |
0.0421 |
|
ICU length of stay (days) |
|||
|
ITT |
3 (2-5) |
3 (0.5-5) |
0.789 |
|
Per protocol |
3 (2-6) |
3 (2-5) |
0.368 |
|
Rehospitalization (ITT only) |
2 (3.33%) |
6 (10%) |
0.272 |
|
Morbidity (day 30) |
|||
|
Patients with complications |
|||
|
ITT |
18 (30%) |
35 (58.3%) |
0.0033 |
|
Per protocol |
16 (31.37%) |
32 (59.26%) |
0.0076 |
|
Patient with severe complication(*) |
|||
|
ITT |
7 (11.7%) |
22 (36.6%) |
0.0028 |
|
Per protocol |
6 (11.76%) |
19 (35.19%) |
0.0097 |
|
Complications (day 30) |
|||
|
ITT |
34 |
77 |
0.0066 |
|
Per protocol |
32 |
73 |
0.0141 |
|
Severe complications (day 30) (*) |
|||
|
ITT |
13 |
41 |
0.0132 |
|
Per protocol |
12 |
38 |
0.0274 |
|
List of complications (ITT only) |
|||
|
Infectious |
|||
|
Pneumonia * |
4 |
8 |
|
|
Sepsis * |
1 |
8 |
|
|
Intraabdominal infection * |
1 |
4 |
|
|
Catheter-related bloodstream inf. * |
1 |
8 |
|
|
Urinary tract infection |
3 |
13 |
|
|
Wound infection/dehiscence |
2 |
5 |
|
|
Decubital inf. |
1 |
3 |
|
|
Cardiovascular |
|||
|
Arrhythmias (non-life threatening) |
3 |
5 |
|
|
Arrhythmias (life threatening) * |
0 |
0 |
|
|
Heart failure/Pulmonary edema * |
3 |
6 |
|
|
Acute myocardial infarction * |
0 |
1 |
|
|
Respiratory |
|||
|
Pulmonary embolism * |
0 |
0 |
|
|
ALI/ARDS * |
0 |
0 |
|
|
Ventilator support (incl.postoperative) |
3 |
6 |
|
|
New onset of ventilator support * |
2 |
4 |
|
|
Renal |
|||
|
AKI (without dialysis) |
2 |
4 |
|
|
Renal failure with dialysis * |
1 |
1 |
|
|
Thrombotic |
|||
|
Stroke (including TIA) * |
0 |
1 |
|
|
Deep vein thrombosis |
0 |
1 |
|
|
Graft thrombosis |
1 |
3 |
|
|
Gastro-intestinal |
|||
|
GIT bleeding |
0 |
0 |
|
|
GIT obstruction |
0 |
0 |
|
|
Pancreatitis (edematous/necrotizing *) |
2/0 |
0/0 |
|
|
Hepatic dysfunction (mild/severe *) |
0/0 |
1/0 |
|
|
|
|||
|
Values are presented as absolute (percentage) or median (interquartile range). * Complication deemed as severe (life disabling or threatening). AKI, acute kidney injury; ALI/ARDS, acute lung injury/acute respiratory distress syndrome; GIT, gastro-intestinal tract; ITT, intention to treat analysis; Per protocol, only patients whose intraoperative protocol was carried in full extent; TIA, transient ischemic attack. |
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|
Benes et al. Critical Care 2010 14:R118 doi:10.1186/cc9070 |
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