Daily laxative therapy reduces organ dysfunction in mechanically ventilated patients: a phase II randomized controlled trial

Table 3 Clinical outcomes of patients in both study groups

Variables	Intervention	Control	Mean difference	p value^a
Variables	(n = 44)	(n = 44)	(control – intervention) or relative risk (95 % CI)^a	p value^a
Primary outcome
ΔSOFA^b	–4.0 (–6.0 to 0)	–1.0 (–4.0 to 1.0)	–1.907 (–3.683 to 0.13)^c	0.036
SOFA at outcome assessment	4.0 (3.0 to 7.0)	5.5 (3.0 to8.7)	-	-
Secondary outcomes
TISS-28 score
Daily average	31.2 ± 6.41	30.7 ± 5.28	0.077 (–2.335 to 2.49)^c	0.949
Total sum	419.0 (252.5 to 640.5)	433.0 (224.5 to 610.0)	24.4 (–73.8 to 122.7)^c	0.622
Length of ICU stay (days)	16.0 (10.0 to 23.0)	16.0 (10.0 to 21.0)	–1.843 (–5.119 to 1.433)^c	0.277
Length of hospital stay (days)	32.5 (18.2 to 49.5)	27.0 (17.0 to 56.7)	–3.19 (–28.275 to 21.894)^c	0.804
New infection	19 (43.2)	12 (27.3)	1.673 (0.936 to 3.149)^d	0.087
Number of new infections	0 (0 to 1.0)	0 (0 to 1.0)	1.627 (0.821 to 3.325)^d	0.172
Pneumonia	17 (38.6)	10 (22.7)	1.79 (0.936 to 3.655)^d	0.085
UTI	4 (9.1)	2 (4.5)	2.531 (0.508 to 17.677)^d	0.264
CRBSI	2 (4.5)	2 (4.5)	0.815 (0.094 to 6.994)^d	0.836
Bacteremia	5 (11.6)	9 (20.9)	0.397 (0.128 to 1.124)^d	0.067
Severe sepsis/septic shock	12 (27.6)	14 (31.8)	0.842 (0.428 to 1.625)^d	0.607
New organ dysfunction	23 (52.3)	24 (54.5)	0.932 (0.621 to 1.396)^d	0.726
Ventilator-free days in 28 days	16.5 (11.0 to 21.7)	20.0 (13.2 to 24.0)	–1.371 (–4.569 to 1.826)^c	0.396
Mortality
Day 28	10 (22.7)	16 (36.4)	1.29 (0.973; 1.715)^d	0.081
ICU	11 (25.0)	17 (38.6)	1.311 (0.975; 1.767)^d	0.077
Hospital	13 (29.5)	19 (43.2)	1.294 (0.932; 1.803)^d	0.129

Results are expressed as number (%), mean ± standard deviation or median (25th to 75th percentile)
^aGeneralized linear model with gaussian family with identity link or quasipoisson with log link, or binomial with log link as appropriate; models were controlled by APACHE score and SOFA at baseline
^bΔSOFA is the change in SOFA score between the date of enrollment (day 0) and the day of outcome assessment. Outcome was assessed at ICU discharge, death or day 15 after enrollment, whichever came first
^cmean difference between groups estimated with delta method from a quasipoisson regression considering median APACHE and SOFA scores at baseline
^dRelative risk
APACHE Acute Physiologic Chronic Health Evaluation, CI confidence interval, CRBSI catheter-related bloodstream infection, ICU intensive care unit, SOFA Sequential Organ Failure Assessment score, TISS-28 Therapeutic Intervention Scoring System-28, UTI urinary tract infection

ISSN: 1364-8535