Background
Methods
Objectives
Inclusion and exclusion criteria
Test products
Feeding protocol
Statistics
Results
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | |||
---|---|---|---|---|
Age, years |
n = 46 | 65.3 (52.6–75.3) |
n = 44 | 61.6 (48.6–71.3) |
Sex, male |
n = 46 | 33 (72%) |
n = 44 | 28 (64%) |
Body mass index, kg/m2
|
n = 41 | 28.8 (25.1–34.2) |
n = 41 | 27.8 (23.5–31.5) |
APACHE II admission diagnosis |
n = 44 | 28.5 (22.3–32.8) |
n = 42 | 27.5 (22.0–33.3) |
SAPS II admission diagnosis |
n = 46 | 60.5 (46.5–74.0) |
n = 44 | 61.5 (48.5–75.5) |
SOFA |
n = 45 | 8.0 (6.0–11.0) |
n = 44 | 7.0 (5.0–10.0) |
Mechanical ventilation |
n = 46 | 43 (94%) |
n = 44 | 43 (98%) |
Treated with vasoactive drugs |
n = 46 | 31 (67%) |
n = 44 | 29 (66%) |
Diabetes |
n = 46 | 13 (28%) |
n = 44 | 8 (18%) |
Residual gastric volume at study inclusion, ml |
n = 42 | 35.0 (10.0–112.5) |
n = 43 | 50.0 (20.0–100.0) |
Presence of diarrhea at study inclusion |
n = 46 | 5 (11%) |
n = 44 | 4 (9%) |
Blood glucose at study inclusion, mmol/l |
n = 46 | 7.8 (6.8–8.9) |
n = 44 | 8.3 (6.9–9.4) |
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | Treatment effect |
p value | |||
---|---|---|---|---|---|---|
n
| Median (IQR) |
n
| Median (IQR) | Median differencea (95% CI) | ||
Calorie intake, Kcal/kg/day | 41 | 18.0 (12.5–20.9) | 38 | 19.7 (17.3–23.1) | −2.6 (−5.3 to 0.2) | 0.08 |
Protein intake, g/kg/day | 41 | 1.13 (0.78–1.31) | 38 | 0.80 (0.70–0.94) | 0.27 (0.12–0.43) | <0.001 |
Accumulated caloric deficit during EN/day, Kcal | 45 | −410 (−984 to −115) | 43 | −171 (−455 to −4) | −222 (−438 to −45) | 0.014 |
n
|
Median (95% CI)
|
n
|
Median (95% CI)
|
HR (95% CI)
| ||
Length of EN, days | 46 | 5.0 (3.6– to 6.4) | 44 | 7.0 (5.3– to 8.7) | 1.35 (0.80–2.26) | 0.26 |
Time to reach the full caloric goal, days | 46 | 2.2 (0.8– to 3.7) | 44 | 2.0 (1.3– to 2.7) | 0.70 (0.42–1.16) | 0.16 |
n
|
No. of events (pd)
|
n
|
No. of events (pd)
|
Rate ratio (95% CI)
| ||
Days with parenteral nutrition supplementation | 46 | 5 (253 pd) | 44 | 2 (287 pd) | 2.84 (0.28–28.61) | 0.38 |
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | Treatment effect |
p value | |||
---|---|---|---|---|---|---|
n
|
n (%) with event |
n
|
n (%) with event | Risk ratio (95% CI) | ||
Patients that experienced diarrhea during their ICU stay | 45 | 29 (64%) | 44 | 31 (70%) | 0.91 (0.68–1.22) | 0.65 |
Patients receiving a fecal collector during their ICU stay | 45 | 23 (51%) | 44 | 24 (55%) | 0.94 (0.63–1.39) | 0.83 |
n
|
No. of events (pd)
|
n
|
No. of events (pd)
|
Rate ratio (95% CI)
| ||
Days with interruption of EN due to diarrhea | 46 | 0 (253 pd) | 44 | 2 (287 pd) | nd | 0.28 |
n
|
Median (IQR)
|
n
|
Median (IQR)
|
Median difference
a
(95% CI)
| ||
Total costs of diarrhea per patient/day, CHF | 45 | 3.66 (0.00–8.73) | 44 | 2.60 (0.00–6.39) | 0.00 (−0.36 to 2.70) | 0.35 |
Nurse workload per patient/day, min | 45 | 17.0 (0.0–38.5) | 44 | 13.1 (0.0–21.5) | 2.5 (−0.7 to 11.8) | 0.28 |
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | Rate or risk ratio (95% CI) |
p value | |
---|---|---|---|---|
Stool events | ||||
Intention to treat | 542 (253 pd) | 415 (287 pd) | 1.34 (0.89 to 2.02) | 0.16 |
Adjusted for baseline diarrhea | 542 (253 pd) | 415 (287 pd) | 1.28 (0.86 to 1.90) | 0.23 |
Adjusted for antibiotics prescription | 542 (253 pd) | 415 (287 pd) | 1.34 (0.89 to 2.02) | 0.16 |
Per protocola
| 527 (237 pd) | 401 (273 pd) | 1.41 (0.92 to 2.15) | 0.11 |
Diarrhea-free days | ||||
Intention to treat | 161 (64%) | 196 (68%) | 0.82 (0.36 to 1.90) | 0.65 |
Adjusted for baseline diarrhea | 161 (64%) | 196 (68%) | 0.83 (0.38 to 1.82) | 0.64 |
Adjusted for antibiotics prescription | 161 (64%) | 196 (68%) | 0.83 (0.36 to 1.92) | 0.66 |
Per protocola
| 149 (63%) | 185 (68%) | 0.82 (0.34 to 1.96) | 0.65 |
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | Treatment effect |
p value | |||
---|---|---|---|---|---|---|
n
| Median (IQR) |
n
| Median (IQR) | Median differencea (95% CI) | ||
Serum albumin at baseline | 39 | 21.0 (17.0–25.0) | 42 | 21.3 (18.0–24.0) | 0.0 (−2.0 to 2.0) | 0.93 |
Serum albumin at treatment end or at ICU discharge | 17 | 21.0 (19.0–26.0) | 19 | 23.0 (18.0–26.0) | 0.00 (−3.00 to 3.00) | 0.99 |
n
|
No. of events (pd)
|
n
|
No. of events (pd)
|
Rate ratio (95% CI)
| ||
Number of events outside the 4.5–10 mmol/l glycemic range | 46 | 425 (253 pd) | 44 | 582 (287 pd) | 0.83 (0.54–1.28) | 0.39 |
Peptamen® AF (n = 46) | Isosource® Energy (n = 44) | Treatment effect |
p value | |||
---|---|---|---|---|---|---|
n
| No. of events (pd) |
n
| No. of events (pd) | Rate ratio (95% CI) | ||
Secondary infections | 46 | 19 (253 pd) | 44 | 19 (287 pd) | 1.13 (0.70 to 1.84) | 0.61 |
n
|
Median time (95% CI)
|
n
|
Median time (95% CI)
|
HR (95% CI)
| ||
Length of mechanical ventilation, days | 46 | 6.2 (4.8–7.7) | 44 | 7.0 (4.7–9.3) | 1.33 (0.83–2.11) | 0.23 |
Length of ICU stay, days | 46 | 7.0 (5.3–8.7) | 44 | 10.0 (6.6–13.4) | 1.27 (0.81–2.02) | 0.30 |
Length of hospital stay, days | 46 | 31.0 (27.0–35.0) | 44 | 36.0 (29.9–42.1) | 1.01 (0.54–1.89) | 0.97 |
Patients with diarrhea (n = 60) | Patients without diarrhea (n = 30) |
p value | |||
---|---|---|---|---|---|
Receiving Peptamen® AF |
n = 60 | 29 (48%) |
n = 30 | 17 (57%) | 0.51 |
Age, years |
n = 60 | 63.7 (51.0–74.3) |
n = 30 | 61.7 (50.5–72.8) | 0.71 |
Sex, male |
n = 60 | 41 (68%) |
n = 30 | 20 (67%) | 1.00 |
Body mass index, kg/m2
|
n = 54 | 28.1 (23.6–33.8) |
n = 28 | 28.2 (23.9–32.6) | 0.83 |
APACHE II score |
n = 57 | 30.0 (25.0–36.0) |
n = 29 | 26.0 (20.0–30.0) | 0.005 |
SAPS II score |
n = 60 | 66.0 (53.5–76.8) |
n = 30 | 52.0 (43.8–63.8) | 0.003 |
Diabetes |
n = 60 | 12 (20%) |
n = 30 | 9 (30%) | 0.30 |
Residual gastric volume at study inclusion, ml |
n = 58 | 41.0 (20.0–112.5) |
n = 27 | 30.0 (10.0–80.0) | 0.19 |
Presence of diarrhea at study inclusion |
n = 60 | 8 (13%) |
n = 30 | 1 (3%) | 0.26 |
Blood glucose at study inclusion, mmol/l |
n = 60 | 8.2 (7.0–9.4) |
n = 30 | 8.0 (6.6–8.9) | 0.43 |
Patients with diarrhea (n = 60) | Patients without diarrhea (n = 30) | Effect of diarrhea |
p value | |||
---|---|---|---|---|---|---|
n
|
n (%) with event |
n
|
n (%) with event | Risk ratio (95% CI) | ||
Death | 60 | 16 (27%) | 29 | 7 (24%) | 0.68 (0.26 to 1.78) | 0.44 |
n
|
Median (IQR)
|
n
|
Median (IQR)
|
Median difference (95% CI)
| ||
Maximal abdominal pain per patient/staya
| 42 | 0.00 (0.00–3.00) | 19 | 2.00 (0.00–4.00) | −0.8 (−2.9 to 1.4) | 0.47 |
Mean abdominal pain per patient/staya
| 42 | 0.00 (0.00–1.00) | 19 | 0.67 (0.00–2.00) | −0.4 (−1.4 to 0.7) | 0.49 |
Accumulated caloric deficit 3 days after start of EN, Kcal | 59 | −888 (−1828 to −266) | 29 | −924 (−1521 to −230) | −175 (−813 to 463) | 0.59 |
Accumulated caloric deficit during EN/day, Kcal | 59 | −268 (−521 to −41) | 29 | −455 (−1008 to −78) | 248 (−67 to 563) | 0.12 |
Percentage of cumulative calories delivered vs. prescribed during EN | 59 | 0.90 (0.81–0.96) | 29 | 0.85 (0.74–0.95) | 0.01 (−0.10 to 0.11) | 0.91 |
Serum albumin at baseline, g/L | 53 | 20.0 (16.0–23.0) | 28 | 24.0 (21.0–26.0) | −2.6 (−5.2 to −0.0) | 0.050 |
Serum albumin 3 days after EN start, g/L | 43 | 18.0 (14.0–24.0) | 11 | 23.0 (17.0–25.0) | −0.7 (−4.7 to 3.2) | 0.72 |
Serum albumin at treatment end or at ICU discharge, g/L | 23 | 20.0 (17.0–26.0) | 13 | 24.0 (21.0–25.0) | −0.8 (−4.7 to 3.2) | 0.69 |
n
|
No. of events (pd)
|
n
|
No. of events (pd)
|
Rate ratio (95% CI)
| ||
Stool events | 60 | 911 (418 pd) | 30 | 46 (122 pd) | 4.60 (2.98–7.11) | <0.001 |
Days with interruption of EN due to diarrhea | 60 | 2 (418 pd) | 30 | 0 (122 pd) | nd | |
Days with presence of electrolyte and acid-base disturbances | 60 | 350 (418 pd) | 30 | 102 (122 pd) | 0.97 (0.88–1.09) | 0.64 |
Days with presence of electrolyte disturbances | 60 | 346 (418 pd) | 30 | 98 (122 pd) | 1.01 (0.90–1.13) | 0.88 |
Days with presence of acid-base disturbances | 60 | 42 (418 pd) | 30 | 17 (122 pd) | 0.48 (0.27–0.84) | 0.010 |
Changes in intra-abdominal pressure | 60 | 250 (418 pd) | 30 | 53 (122 pd) | 1.21 (0.68–2.13) | 0.51 |
Diarrhea due to medication | 60 | 18 (418 pd) | 30 | 0 (122 pd) | nd | |
Days with drug interfering with the passage of nutrition | 60 | 150 (418 pd) | 30 | 26 (122 pd) | 1.50 (0.76–2.95) | 0.25 |
Number of events outside the 4.5–10 mmol/l glycemic range | 60 | 748 (418 pd) | 30 | 259 (122 pd) | 0.58 (0.34–1.01) | 0.05 |
Number of events above the 4.5–10 mmol/l glycemic range | 60 | 738 (418 pd) | 30 | 259 (122 pd) | 0.58 (0.33–1.00) | 0.05 |
Number of events below the 4.5–10 mmol/l glycemic range | 60 | 10 (418 pd) | 30 | 0 (122 pd) | nd | |
Secondary infections | 60 | 28 (418 pd) | 30 | 10 (122 pd) | 0.66 (0.36–1.20) | 0.17 |
Days with mechanical ventilation | 60 | 242 (418 pd) | 30 | 68 (122 pd) | 0.98 (0.78–1.24) | 0.86 |
n
|
Median time (95% CI)
|
n
|
Median time (95% CI)
|
HR (95% CI)
| ||
Length of EN, days | 60 | 8.0 (5.9–10.1) | 30 | 4.0 (2.9–5.1) | 0.36 (0.20–0.64) | <0.001 |
Length of ICU stay, days | 60 | 11.0 (8.9–13.1) | 30 | 5.0 (3.8–6.2) | 0.40 (0.23–0.71) | 0.001 |
Length of hospital stay, days | 60 | 36.0 (29.6–42.4) | 30 | 31.0 (17.6–44.4) | 0.67 (0.33–1.39) | 0.29 |
Length of mechanical ventilation, days | 60 | 9.5 (6.0–13.1) | 30 | 3.9 (3.2–4.6) | 0.46 (0.27–0.81) | 0.006 |
Time to reach the full caloric goal, days | 60 | 1.9 (0.9–3.0) | 30 | 2.5 (1.7–3.3) | 1.11 (0.59–2.07) | 0.75 |