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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