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Table 8 Post-hoc comparison of patients with and without diarrhea

From: A randomized controlled pilot study to evaluate the effect of an enteral formulation designed to improve gastrointestinal tolerance in the critically ill patient—the SPIRIT trial

 

Patients with diarrhea (n = 60)

Patients without diarrhea (n = 30)

Effect of diarrhea

p value

 

n

n (%) with event

n

n (%) with event

Risk ratio (95% CI)

 

Death

60

16 (27%)

29

7 (24%)

0.68 (0.26 to 1.78)

0.44

 

n

Median (IQR)

n

Median (IQR)

Median difference (95% CI)

 

Maximal abdominal pain per patient/staya

42

0.00 (0.00–3.00)

19

2.00 (0.00–4.00)

−0.8 (−2.9 to 1.4)

0.47

Mean abdominal pain per patient/staya

42

0.00 (0.00–1.00)

19

0.67 (0.00–2.00)

−0.4 (−1.4 to 0.7)

0.49

Accumulated caloric deficit 3 days after start of EN, Kcal

59

−888 (−1828 to −266)

29

−924 (−1521 to −230)

−175 (−813 to 463)

0.59

Accumulated caloric deficit during EN/day, Kcal

59

−268 (−521 to −41)

29

−455 (−1008 to −78)

248 (−67 to 563)

0.12

Percentage of cumulative calories delivered vs. prescribed during EN

59

0.90 (0.81–0.96)

29

0.85 (0.74–0.95)

0.01 (−0.10 to 0.11)

0.91

Serum albumin at baseline, g/L

53

20.0 (16.0–23.0)

28

24.0 (21.0–26.0)

−2.6 (−5.2 to −0.0)

0.050

Serum albumin 3 days after EN start, g/L

43

18.0 (14.0–24.0)

11

23.0 (17.0–25.0)

−0.7 (−4.7 to 3.2)

0.72

Serum albumin at treatment end or at ICU discharge, g/L

23

20.0 (17.0–26.0)

13

24.0 (21.0–25.0)

−0.8 (−4.7 to 3.2)

0.69

 

n

No. of events (pd)

n

No. of events (pd)

Rate ratio (95% CI)

 

Stool events

60

911 (418 pd)

30

46 (122 pd)

4.60 (2.98–7.11)

<0.001

Days with interruption of EN due to diarrhea

60

2 (418 pd)

30

0 (122 pd)

nd

 

Days with presence of electrolyte and acid-base disturbances

60

350 (418 pd)

30

102 (122 pd)

0.97 (0.88–1.09)

0.64

Days with presence of electrolyte disturbances

60

346 (418 pd)

30

98 (122 pd)

1.01 (0.90–1.13)

0.88

Days with presence of acid-base disturbances

60

42 (418 pd)

30

17 (122 pd)

0.48 (0.27–0.84)

0.010

Changes in intra-abdominal pressure

60

250 (418 pd)

30

53 (122 pd)

1.21 (0.68–2.13)

0.51

Diarrhea due to medication

60

18 (418 pd)

30

0 (122 pd)

nd

 

Days with drug interfering with the passage of nutrition

60

150 (418 pd)

30

26 (122 pd)

1.50 (0.76–2.95)

0.25

Number of events outside the 4.5–10 mmol/l glycemic range

60

748 (418 pd)

30

259 (122 pd)

0.58 (0.34–1.01)

0.05

Number of events above the 4.5–10 mmol/l glycemic range

60

738 (418 pd)

30

259 (122 pd)

0.58 (0.33–1.00)

0.05

Number of events below the 4.5–10 mmol/l glycemic range

60

10 (418 pd)

30

0 (122 pd)

nd

 

Secondary infections

60

28 (418 pd)

30

10 (122 pd)

0.66 (0.36–1.20)

0.17

Days with mechanical ventilation

60

242 (418 pd)

30

68 (122 pd)

0.98 (0.78–1.24)

0.86

 

n

Median time (95% CI)

n

Median time (95% CI)

HR (95% CI)

 

Length of EN, days

60

8.0 (5.9–10.1)

30

4.0 (2.9–5.1)

0.36 (0.20–0.64)

<0.001

Length of ICU stay, days

60

11.0 (8.9–13.1)

30

5.0 (3.8–6.2)

0.40 (0.23–0.71)

0.001

Length of hospital stay, days

60

36.0 (29.6–42.4)

30

31.0 (17.6–44.4)

0.67 (0.33–1.39)

0.29

Length of mechanical ventilation, days

60

9.5 (6.0–13.1)

30

3.9 (3.2–4.6)

0.46 (0.27–0.81)

0.006

Time to reach the full caloric goal, days

60

1.9 (0.9–3.0)

30

2.5 (1.7–3.3)

1.11 (0.59–2.07)

0.75

  1. Effects from an adjusted analysis (for treatment group, age, sex, and Simplified Acute Physiology Score (SAPS) II admission diagnosis) are shown
  2. aPatient-assessed, only in non-comatose patients
  3. CI confidence interval, EN enteral nutrition, HR hazard ratio, ICU intensive care unit, IQR interquartile range, nd not defined, pd person days