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Table 4 Primary endpoints

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

  Peptamen® AF (n = 46) Isosource® Energy (n = 44) Rate or risk ratio (95% CI) p value
Stool events
 Intention to treat 542 (253 pd) 415 (287 pd) 1.34 (0.89 to 2.02) 0.16
 Adjusted for baseline diarrhea 542 (253 pd) 415 (287 pd) 1.28 (0.86 to 1.90) 0.23
 Adjusted for antibiotics prescription 542 (253 pd) 415 (287 pd) 1.34 (0.89 to 2.02) 0.16
 Per protocola 527 (237 pd) 401 (273 pd) 1.41 (0.92 to 2.15) 0.11
Diarrhea-free days
 Intention to treat 161 (64%) 196 (68%) 0.82 (0.36 to 1.90) 0.65
 Adjusted for baseline diarrhea 161 (64%) 196 (68%) 0.83 (0.38 to 1.82) 0.64
 Adjusted for antibiotics prescription 161 (64%) 196 (68%) 0.83 (0.36 to 1.92) 0.66
 Per protocola 149 (63%) 185 (68%) 0.82 (0.34 to 1.96) 0.65
  1. a n = 37 in both groups
  2. CI confidence interval, pd person days