Table 2. Primary and Secondary Clinical Outcomes During the Intervention and Follow-upa.
| Outcome | E-SPN (n = 115) | L-SPN (n = 114) | Absolute difference (95% CI) | P value |
|---|---|---|---|---|
| Primary outcome | ||||
| Infectious complications | 10 (8.7) | 21 (18.4) | 9.7 (0.9 to 18.5) | .04 |
| Major infectious | ||||
| Pneumonia | 5 (4.3) | 11 (9.6) | 8.8 (0.7 to 17.0) | .04 |
| Abdominal infection | 1 (0.9) | 4 (3.5) | ||
| Septic shock | 0 (0.0) | 2 (1.8) | ||
| Bloodstream infection | 2 (1.7) | 1 (0.9) | ||
| Minor infectious | ||||
| Surgical site infection | 1 (0.9) | 2 (1.8) | 0.9 (−2.9 to 4.7) | .68 |
| Urinary tract infection | 1 (0.9) | 1 (0.9) | ||
| Secondary outcomes | ||||
| Noninfectious complications | 31 (27.0) | 38 (33.3) | 6.4 (−5.5 to 18.2) | .32 |
| Major noninfectious | 14 (12.2) | 19 (16.7) | 4.5 (−4.6 to 13.6) | .35 |
| Minor noninfectious | 17 (14.8) | 19 (16.7) | 1.9 (−7.5 to 11.3) | .72 |
| Total adverse effects | 75 (65.2) | 82 (71.9) | 6.7 (−5.3 to 18.7) | .32 |
| GI intolerance complications | 67 (58.3) | 79 (69.3) | 11.0 (−1.3 to 23.4) | .10 |
| Parenteral nutrition–related complications | 9 (7.8) | 4 (3.5) | −4.3 (−10.3 to 1.6) | .25 |
| Time in hospital, mean (SD), d | 16.6 (8.8) | 17.6 (8.4) | 1.0 (−1.1 to 3.1) | .39 |
| Mechanical ventilatory support | 4 (3.5) | 7 (6.1) | 2.7 (−2.9 to 8.2) | .38 |
| ICU | 7 (6.1) | 9 (7.9) | 1.8 (−4.8 to 8.4) | .62 |
| Mortality | NA | NA | ||
| Hospitalization costs, mean (SD), ¥b | 72 959 (30 147) | 71 239 (22 942) | −1720 (−8700 to 5260) | .63 |
| Antibiotic days, mean (SD) | ||||
| Total | 2.9 (1.4) | 3.3 (2.0) | 0.5 (0.03 to 0.96) | .054 |
| Prophylactic | 2.46 (0.74) | 2.47 (0.78) | 0.01 (−0.20 to 0.23) | .71 |
| Therapeutic | 6.0 (0.8) | 7.0 (1.1) | 1.0 (0.2 to1.9) | .01 |
Abbreviations: E-SPN, early supplemental parenteral nutrition; GI, gastrointestinal; ICU, intensive care unit; L-SPN, late supplemental parenteral nutrition; NA, not applicable.
a
Data are presented as number (percentage) of participants unless otherwise noted. Continuous data, expressed as mean (SD), were compared using the t test or Mann-Whitney U test. Outcomes expressed as percentages of patients with each outcome were compared between the 2 groups using the Fisher exact test. Parenteral nutrition–related complications were hyperglycemia, hypoglycemia, and hyperlipidemia.
b
The current exchange rate of $1 to ¥6.34 was used.