Background
Methods
Design
Patients
Study processes
Common to both groups
Management of the usual care group
Management of the intervention group
Variable | Usual care (n = 48) | Intervention (n = 51) |
---|---|---|
Age, years, mean (SD) | 60 (17) | 59 (17) |
Sex, male, n (%) | 35 (73) | 35 (69) |
BMI, kg/m2, mean (SD) | 30 (6) | 29 (6) |
APACHE II score, mean (SD) | 19 (7) | 18 (7) |
APACHE III diagnosis code, n (%) | ||
Cardiovascular | 29 (59) | 31 (61) |
Trauma | 7 (14) | 6 (12) |
Respiratory | 6 (12) | 3 (6) |
Sepsis | 1 (2) | 7 (14) |
Gastrointestinal | 1 (2) | 2 (4) |
Musculoskeletal | 2 (4) | 0 (0) |
Renal | 1 (2) | 1 (2) |
Unknown | 1 (2) | 1 (2) |
Neurological | 1 (2) | 0 (0) |
Location prior to ICU admission, n (%) | ||
Elective surgery | 20 (42) | 22 (43) |
ICU | 9 (19) | 7 (14) |
Emergency surgery | 9 (19) | 5 (10) |
ED | 5 (10) | 8 (16) |
Ward | 4 (8) | 6 (12) |
Other hospital | 1 (2) | 3 (6) |
Time from hospital admission to randomization, days, median [IQR] | 3 [3–6] | 3 [3–4] |
Time from ICU admission to randomization, days, mean (SD) | 2.5 (0.4) | 2.5 (0.4) |
Baseline total SOFA, mean (SD) | 10 (3) | 10 (4) |
Bloods, median [IQR] | ||
ALT, U/L | 25 [11–103] | 40 [18–108] |
ALP, U/L | 67 [49–97] | 72 [50–89] |
GGT, U/L, mean (SD) | 44 [27–79] | 41 [28–98] |
Bilirubin, mmol/L | 21 [10–41] | 24 [11–47] |
WCC, 0^9/L | 13 [10–15] | 17 [11–23] |
TG, mmol/L | 2 [1–3] | 2 [1–3] |
CRP, mg/L | 209 (97) | 217 (111) |
Mid arm muscle circumference, cm, mean (SD) | 34 (5) | 34 (4) |
Data collection
Outcomes
Statistical analysis
Results
Patients
Baseline characteristics
Nutrition delivery
Variable | Usual care (n = 48) | Intervention (n = 51) | p value |
---|---|---|---|
7-day intervention period, mean (SD) | |||
Delivery of energy from EN and PN, kcal | 1130 (601) | 1712 (511) | <0.0001 |
Proportion of energy from EN and PN, % | 54 (28) | 83 (22) | <0.0001 |
Energy from EN and PN, kcal/kg | 13 (6.6) | 20.6 (6.3) | <0.0001 |
Delivery of energy from all sources, kcal | 1298 (671) | 1892 (540) | <0.0001 |
Proportion of energy from all sources, % | 62 (31) | 92 (22) | <0.0001 |
Energy from all sources, kcal/kg | 16.8 (8.2) | 24.9 (6.4) | <0.0001 |
Delivery of protein, g | 53.3 (28.5) | 85.6 (25.4) | <0.0001 |
Proportion of protein, % | 51 (25) | 86 (23) | <0.0001 |
Protein delivery, g/kg | 0.6 (0.3) | 1.0 (0.3) | <0.0001 |
ICU stay, mean (SD) | |||
Delivery of energy from EN and PN, kcal | 1212 (676) | 1599 (458) | 0.001 |
Proportion of energy from EN and PN, % | 58 (30) | 78 (21) | <0.0001 |
Energy from EN and PN, kcal/kg | 13.9 (7.4) | 19.2 (5.7) | <0.0001 |
Delivery of energy from all sources, kcal | 1331 (720) | 1718 (468) | 0.002 |
Proportion of energy from all sources, % | 63 (32) | 84 (21) | <0.0001 |
Energy from all sources, kcal/kg | 15.3 (7.8) | 20.6 (5.7) | <0.0001 |
Delivery of protein, g | 57 (33) | 79 (23) | <0.0001 |
Proportion of protein, % | 54 (29) | 80 (22) | <0.0001 |
Protein delivery, g/kg | 0.7 (0.3) | 1.0 (0.3) | <0.0001 |
Other outcomes
Variable | n | Usual care | n | Intervention | p value |
---|---|---|---|---|---|
Patients with reported complications during study period, n (%) | |||||
GRV > 300 ml on study days 1–7 | 48 | 23 (48) | 51 | 28 (55) | 0.49 |
Abdominal distention | 14 (29) | 16 (31) | 0.81 | ||
Vomiting | 8 (17) | 13 (26) | 0.28 | ||
Calories from propofol over the study period, kcal, median [IQR] | 48 | 0 [0-110] | 51 | 0 [0-160] | 0.48 |
Blood test results on study day 7: | |||||
ALP, U/L, mean (SD) | 38 | 165 (81) | 33 | 183 (103) | 0.40 |
ALT, U/L, median [IQR] | 38 | 50 [23-86] | 34 | 58 [30-102] | 0.54 |
GGT, U/L, mean (SD) | 38 | 196 (125) | 34 | 216 (126) | 0.51 |
Bilirubin, mmol/L, median [IQR] | 38 | 15 [11-29] | 35 | 24 [14-53] | 0.47 |
WCC, 0^9/L, mean (SD) | 38 | 18 (10) | 36 | 20 (10) | 0.18 |
TG, mmol/L, median [IQR] | 37 | 2 [1-3] | 32 | 2 [2-4] | 0.18 |
CRP, mg/L, median [IQR] | 37 | 110 [78-185] | 32 | 153 [105-216] | 0.06 |
Mean SOFA over study duration, mean (SE) | 48 | 8.0 (0.4) | 51 | 8.2 (0.4) | 0.75 |
Duration of mechanical ventilation, days, median [IQR] | 48 | 8 [5-18] | 51 | 10 [6-15] | 0.68 |
Duration of ICU stay, days, median [IQR] | 48 | 11 [6-17] | 51 | 11 [5-17] | 0.83 |
Duration of hospital stay, days, mean (SD) | 48 | 23 (17) | 51 | 22 (21) | 0.85 |
Survival | |||||
ICU D/C, n (%) | 37 (77) | 36 (71) | 0.46 | ||
Hospital D/C, n (%) | 48 | 37 (77) | 51 | 35 (67) | 0.37 |
90 days, n (%) | 35 (73) | 32 (63) | 0.28 | ||
180 days, n (%) | 35 (73) | 32 (63) | 0.28 | ||
EQ-5D-3L | |||||
Hospital D/C, mean (SD) | 17 | 0.32 (0.36) | 27 | 0.25 (0.34) | 0.54 |
90 days, median [IQR] | 29 | 0.76 (0.23) | 35 | 0.69 (0.24) | 0.29 |
180 days, mean (SD) | 29 | 0.77 (0.24) | 35 | 0.75 (0.26) | 0.76 |
Hand grip strength at hospital D/C, kg, mean (SD) | 24 | 20 (8) | 19 | 19 (13.5) | 0.71 |
ICU mobility scale at hospital D/C, median [IQR] | 33 | 8 [4-10] | 25 | 9 [5-10] | 0.58 |
Mid arm muscle circumference, hospital D/C, cm, mean (SD) | 25 | 30 (5) | 22 | 30 (5) | 0.91 |