Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-blind randomized trial

Table 2 Gastrointestinal and clinical outcomes

		SHPF group (n = 22)	VHPF group (n = 22)	P value
Incidence of gastrointestinal tolerance parameters^a
Diarrhea	n (%)	11 (50.0%)	8 (36.4%)	0.361^b
Constipation	n (%)	16 (72.7%)	13 (59.1%)	0.340^b
High gastric residual volume (> 500 ml)	n (%)	5 (22.7%)	4 (18.2%)	0.567^c
Vomiting	n (%)	6 (27.3%)	5 (22.7%)	1.000^d
Clinical outcome parameters
Mortality rate
Total 28 days	n (%)	3 (13.6%)	2 (9.1%)	0.560^e
Total 42 days	n (%)	3 (13.6%)	3 (13.6%)	0.886^e
Hospital	n (%)	3 (13.6%)	2 (9.1%)	0.638^c
ICU	n (%)	2 (9.1%)	1 (4.5%)	0.637^c
Duration of ICU stay (day)	mean (SD)	18.3 (12.7)	18.4 (13.4)	0.913^f
	95% CI	12.7–23.9	12.4–24.3
Duration of hospital stay (day)	Mean (SD)	28.2 (13.2)	28.5 (13.3)	0.955^f
	95% CI	22.4–34.1	22.5–34.4
Duration of first ventilation period (day)	Mean (SD)	7.4 (5.4)	10.0 (8.7)	0.234^f
	95% CI	5.0–9.8	6.1–13.9
SOFA scores
Screening	median [IQR]	9 [7–11]	10 [9–11]	0.514^g
Day 5	Median [IQR]	6 [4–8]	6 [3–8]	0.647^g
Day 10	Median [IQR]	5 [4–9]	4 [1–7]	0.432^g
End of study	Median [IQR]	2 [1–3]	2 [1–3]	0.608^g
Day 28	Median [IQR]	1 [0–2]	3 [2–3]	0.446^g

Abbreviations: SOFA Sequential Organ Failure Assessment, ICU Intensive care unit, SHPF Standard high protein formula, VHPF Very high protein formula
^aIncidence is defined as at least one event during the first 10 days of the intervention period
^bP value derived by chi-square test
^cP value derived by Cochran-Mantel-Haenszel test
^dP value derived by Fisher’s exact test
^eP value derived by Cox proportional hazards regression analysis with study product and site as stratification factors
^fP value derived by two-way analysis of variance with treatment and center as factors. Four subjects were not discharged from the ICU at follow-up. For these subjects, ICU and hospital stays were limited to day of follow-up (day 42 ± 3 days)
^gP value derived by van Elteren test (stratified for center)

ISSN: 1364-8535