A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

Table 4 Trial secondary outcomes

	Fluid loading	Fluid control	Odds ratio†	95% CI	P-value
Operative POSSUM score - median (IQR)	12 (9,16)	12 (9,16)	na*	na	na
POMS outcomes
Day 1 POMS morbidity	55 (100%)	53 (98%)	na**	na	na
- Day 3 POMS morbidity	52 (94%)	50 (93%)	1.604	0.277 to 9.279	0.598
- Day 7 POMS morbidity***	23 (51%)	31 (67%)	0.515***	0.200 to 1.326	0.169
Hospital mortality	1 (2%)	1 (2%)	0.981	0.012 to 78.476	1.000
3-month mortality	1 (2%)	3 (6%)	0.315	0.006 to 4.106	0.994
6-month mortality	1 (2%)	4 (8%)	0.231	0.005 to 2.471	0.995

CI,: confidence interval; IQR, Interquartile range; POMS, post-operative morbidity score; POSSUM, Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity.
* statistical significance not tested due to small number of events. ** 100% incidence in fluid group makes testing inappropriate. *** 19 participants (10 in fluid group and 9 in non-fluid group) were discharged less six days after surgery.
†Odds ratios adjusted for minimisation covariates. Post-operative morbidity measured using POMS²⁸ on days 1, 3 and 7 and operative complexity measured using operative POSSUM score²³ and crude mortality at hospital discharge, 3 months and 6 months.

ISSN: 1364-8535