Table 4.
Primary outcome quality measures: intervention
| Variable | EN only (n = 73) | SPN + EN (OLIMEL) (n = 52) | p value |
|---|---|---|---|
| Days from ICU admission to randomization | 1.4 (0.8–2.0) | 1.1 (0.7–1.8) | 0.19 |
| Hours from randomization to start of intervention (SPN + EN arm) | — | 1.6 (0.6–4.9) | — |
| Duration of intervention, days (SPN + EN arm) | — | 5.9 (2.4–7.6) | — |
| Protocol violation: <80% study PN (SPN + EN arm) | — | 13 (25.0%) | — |
| Protocol violation: >120% study PN (SPN + EN arm) | — | 2 (3.8%) | — |
| Other protocol violations and reasons | |||
| Received non-study PN before 7 days | 5 (6.8%) | 0 (0.0%) | 0.05 |
| Received non-study IV lipids before 7 days | 1 (1.4%) | 0 (0.0%) | 0.40 |
| Received protein supplements before 7 days | 1 (1.4%) | 4 (7.7%) | 0.08 |
| Received study PN before 7 days (EN-only arm) | 2 (2.7%) | — | — |
| Other (no further data provided) | 1 (1.4%) | 0 (0.0%) | 0.40 |
| Early deaths or drop-outsa (<72 hrs on protocol) | 1 (1.4%) | 10 (19.2%) | 0.16 |
Data reported as median (Q1–Q3) or n (%). The Mann-Whitney U test was used for continuous variables, and the chi-square test was used for categorical variables
Abbreviations: EN enteral nutrition, ICU intensive care unit, IV intravenous, PN parenteral nutrition, SPN supplemental parenteral nutrition
aThis occurred in the PN group due to the following reasons: goal was reached by EN-alone group in 72 hours (n = 6), transitioned to oral feeds (n = 2), central line removed (n = 1), and fluid overload (n = 1)