A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial

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-outs^a (<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)

ISSN: 1364-8535