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Table 2 Gastrointestinal and clinical outcomes

From: Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial

   SHPF group
(n = 22)
VHPF group
(n = 22)
P value
Incidence of gastrointestinal tolerance parametersa
 Diarrhea n (%) 11 (50.0%) 8 (36.4%) 0.361b
 Constipation n (%) 16 (72.7%) 13 (59.1%) 0.340b
 High gastric residual volume (> 500 ml) n (%) 5 (22.7%) 4 (18.2%) 0.567c
 Vomiting n (%) 6 (27.3%) 5 (22.7%) 1.000d
Clinical outcome parameters
Mortality rate
  Total 28 days n (%) 3 (13.6%) 2 (9.1%) 0.560e
  Total 42 days n (%) 3 (13.6%) 3 (13.6%) 0.886e
  Hospital n (%) 3 (13.6%) 2 (9.1%) 0.638c
  ICU n (%) 2 (9.1%) 1 (4.5%) 0.637c
Duration of ICU stay (day) mean (SD) 18.3 (12.7) 18.4 (13.4) 0.913f
  95% CI 12.7–23.9 12.4–24.3  
Duration of hospital stay (day) Mean (SD) 28.2 (13.2) 28.5 (13.3) 0.955f
  95% CI 22.4–34.1 22.5–34.4  
Duration of first ventilation period (day) Mean (SD) 7.4 (5.4) 10.0 (8.7) 0.234f
  95% CI 5.0–9.8 6.1–13.9  
SOFA scores
 Screening median [IQR] 9 [7–11] 10 [9–11] 0.514g
 Day 5 Median [IQR] 6 [4–8] 6 [3–8] 0.647g
 Day 10 Median [IQR] 5 [4–9] 4 [1–7] 0.432g
 End of study Median [IQR] 2 [1–3] 2 [1–3] 0.608g
 Day 28 Median [IQR] 1 [0–2] 3 [2–3] 0.446g
  1. Abbreviations: SOFA Sequential Organ Failure Assessment, ICU Intensive care unit, SHPF Standard high protein formula, VHPF Very high protein formula
  2. aIncidence is defined as at least one event during the first 10 days of the intervention period
  3. bP value derived by chi-square test
  4. cP value derived by Cochran-Mantel-Haenszel test
  5. dP value derived by Fisher’s exact test
  6. eP value derived by Cox proportional hazards regression analysis with study product and site as stratification factors
  7. fP value derived by two-way analysis of variance with treatment and center as factors. Four subjects were not discharged from the ICU at follow-up. For these subjects, ICU and hospital stays were limited to day of follow-up (day 42 ± 3 days)
  8. gP value derived by van Elteren test (stratified for center)