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Table 3 Primary as well as short- and long-term secondary outcome parameters

From: Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial

 

Control

GDT

Mean diff. (95 % CI)

Odds ratio (95 % CI)

p value

Primary renal outcomes

 Change in creatinine (μmol/l)

18 ± 39

16 ± 42

1.6 (−10 to 13)

 

0.788

 Change in creatinine clearance (ml/min/1.73 m2)

−12 ± 24

−10 ± 24

−2 (−9 to 5)

 

0.566

Secondary outcomes (hospital stay)

 Incidence of acute kidney injury according to RIFLE  (first line: all patients with RIFLE ≥ 1)

45/88 (51 %)

54/92 (59 %)

 

0.73 (0.41 to 1.33)

0.31

R: 29/88

R: 30/92

   

I: 14/88

I: 22/92

   

F: 2/88

F: 2/92

   

 Incidence of acute kidney injury according to KDIGO  (first line: all patients with AKI ≥ 1) (Exploratory endpoint)

46/88 (52 %)

53/92 (58 %)

 

0.81 (0.45 to 1.45)

0.47

1: 34/88

1: 30/92

   

2: 10/88

2: 21/92

   

3: 2/88

3: 2/92

   

 Need for dialysis after RIFLE observation period

4/88 (5 %)

5/92 (5 %)

 

0.83 (0.21 to 3.23)

0.78

 Incidence of ≥1 surgical re-intervention

19/88 (22 %)

24/92 (26 %)

 

0.78 (0.39 to 1.56)

0.48

 Incidence of ≥1 postoperative respiratory complicationa

28/88 (32 %)

28/92 (30 %)

 

1.07 (0.57 to 2.01)

0.84

 Incidence of ≥1 postoperative cardiocirculatory complicationb

2/88 (2 %)

6/92 (7 %)

 

0.33 (0.07 to 1.70)

0.19

 Incidence of postoperative sepsis

7/88 (8 %)

7/92 (8 %)

 

1.05 (0.35 to 3.19)

0.93

 Incidence of postoperative delirium

12/70 (17 %)

18/75 (24 %)

 

0.65 (0.29 to 1.48)

0.31

 In-hospital mortality

4/88 (5 %)

4/92 (4 %)

 

0.79 (0.28 to 2.21)

0.65

Secondary outcome (one year)

 Incidence of hospital re-admission

36/65 (55 %)

28/65 (43 %)

 

1.64 (0.82 to 3.28)

0.16

 Incidence of re-admission to ICU

11/64 (17 %)

11/65 (17 %)

 

1.02 (0.41 to 2.55)

0.97

 Incidence of surgical re-intervention

28/67 (42 %)

20/66 (30 %)

 

1.65 (0.08 to 3.38)

0.17

 Incidence of new need for dialysis after discharge

1/64 (2 %)

2/63 (3 %)

 

0.48 (0.04 to 5.48)

0.56

 Incidence of myocardial infarction

0/64 (0 %)

3/65 (5 %)

 

n.a.

0.24c

 Incidence of stroke

1/64 (2 %)

0/63 (0 %)

 

n.a.

1.00c

 SF-12 Quality of life physical sum score

45.3 ± 9.1

45.0 ± 11.1

0.25 (−4.9 to 5.4)

 

0.92

 SF-12 Quality of life mental sum score

50.6 ± 10.4

50.9 ± 10.3

−0.27 (−5.5 to 5.0)

 

0.92

 One-year overall mortality

16/77 (21 %)

22/77 (29 %)

 

0.66 (0.31 to 1.37)

0.26

  1. Variables of primary renal outcome and SF-12 are given as mean ± standard deviation and variables of secondary outcome as number of patients showing the complication (n) in relation to the number of treated patients within the respective group (N) and incidence (%)
  2. GDT goal-directed haemodynamic therapy, diff. difference, CI confidence interval, RIFLE risk, injury, failure, loss, end-stage kidney disease, R risk, I injury, F failure, KDIGO Kidney Disease: Improving Global Outcome, AKI acute kidney injury, ICU intensive care unit, n.a. not applicable, SF-12 12-item short-form health survey
  3. aPulmonary edema, pleural infection, re-intubation and prolonged ventilation
  4. bMyocardial infarction and prolonged hypotension
  5. cFisher’s exact test
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