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Table 5 Summary of outcomes and complications

From: Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study

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  
  1. Values are presented as absolute (percentage) or median (interquartile range).
  2. * Complication deemed as severe (life disabling or threatening).
  3. 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.