Table 5 Summary of outcomes and complications

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