Table 2. Primary and Secondary Outcomes, and Routinely Collected Data (Landiolol vs Standard Care).
| Landiolol (n = 63) | Standard care (n = 63) | Unadjusteda | Adjustedb | ||||
|---|---|---|---|---|---|---|---|
| Effect estimate (95% CI) | P value | Effect estimate (95% CI) | P value | ||||
| Primary outcome | |||||||
| SOFA score, mean (SD) | 8.8 (3.9) | 8.1 (3.2) | MD, 0.75 (−0.49 to 2.0) | .24 | MD, 0.63 (−0.47 to 1.73) | .26 | |
| Secondary outcomes | |||||||
| 28-d mortality, total/No. (%) | 23/62 (37.1) | 16/63 (25.4) | |||||
| OR (95% CI) | 1.76 (0.77 to 4.03) | .18 | 1.75 (0.73 to 4.22) | .21 | |||
| RD (95% CI), % | 11.70 (−4.43 to 27.83) | .16 | 9.65 (−5.03 to 24.33) | .20 | |||
| 90-d mortality, No./total (%) | 27/62 (43.5) | 18/63 (28.6) | |||||
| OR (95% CI) | 2.04 (0.91 to 4.57) | .08 | 2.13 (0.88 to 5.16) | .09 | |||
| RD (95% CI), % | 14.98 (−1.66 to 31.6) | .08 | 12.77 (2.00 to 27.54) | .09 | |||
| Length of stay, mean (SD) | |||||||
| ICU survivors, d | 21.3 (31.7) | 19.6 (19.3) | MD, 1.72 (−8.94 to 12.39) | .75 | MD, 0.63 (−9.82 to 11.07) | .12 | |
| No. | 42 | 47 | |||||
| Hospital survivors, d | 49.1 (56.8) | 52.2 (42.6) | MD, −3.17 (−24.77 to 18.42) | .77 | MD, −3.88 (−24.66 to 16.88) | .71 | |
| No. | 38 | 42 | |||||
| Duration of norepinephrine, mean (SD), d | 5.3 (4.3) | 4.3 (1.9) | MD, 0.98 (−0.23 to 2.20) | .11 | MD, 1.05 (−0.16 to 2.27) | .09 | |
| No. | 61 | 59 | |||||
| Total cumulative dose of norepinephrine, µg/kg/min | MD, 0.10 (0.002 to 0.20) | .05 | MD, 0.07 (−0.003 to 0.15) | .06 | |||
| Mean (SD) | 0.34 (0.33) | 0.24 (0.23) | |||||
| Median (IQR) | 0.24 (0.16 to 0.37) | 0.17 (0.10 to 0.27) | |||||
| Duration of landiolol, mean (SD), d | 3.4 (4.0) | ||||||
| No. | 60 | ||||||
| Median (IQR) | 2.0 (0.8 to 3.9) | ||||||
| Total cumulative dose of landiolol, mean (SD), µg/kg/min | 10.9 (10.2) | ||||||
| No. | 60 | ||||||
| Median (IQR) | 6.7 (3.3 to 15.0) | ||||||
| Routinely collected data | |||||||
| Cardiovascular | |||||||
| MAP over 5 d, mean (SD), mm Hg | 73.2 (7.6) | 76.0 (6.5) | MD, −2.67 (−5.06 to −0.29) | .03 | MD, −2.64 (−4.94 to −0.33) | .002 | |
| Heart rate over 14 d, mean (SD), beats/min | 92.4 (10.4) | 98.6 (12.2) | MD, −6.46 (−10.46 to −2.46) | .002 | MD, −6.46 (−10.42 to −2.49) | .001 | |
| Glucose and lactate, mg/dL | |||||||
| Glucose | |||||||
| No. | 62 | ||||||
| Mean (SD) | 136.5 (34.5) | 148.3 (38.0) | MD, −10.58 (−23.21 to 2.05) | .10 | MD, −10.70 (−23.37 to 1.97) | .10 | |
| Median (IQR) | 134.2 (112.3 to 152.1) | 140.1 (122.9 to 176.3) | |||||
| Lactate | |||||||
| No. | 62 | ||||||
| Mean (SD), mg/dLa | 32.5 (31.2) | 24.5 (15.6) | MD, 6.48 (−1.12 to 14.08) | .10 | MD, 6.31 (−0.76 to 13.40) | .08 | |
| Median (IQR) | 21.3 (14.9 to 31.5) | 19.7 (15.7 to 25.7) | |||||
| Arterial blood gases, mean (SD), mm Hg | |||||||
| Pao2 | 79.8 (14.4) | 81.6 (21.1) | MD, −1.66 (−7.96 to 4.64) | .61 | MD, −1.55 (−7.83 to 4.72) | .63 | |
| Paco2 | 46.5 (10.2) | 44.8 (10.4) | MD, 1.38 (−1.95 to 4.72) | .42 | MD, 1.40 (−1.99 to 4.79) | .42 | |
| Steroid or hydrocortisone equivalent dose, mean (SD), mg | 167.9 (72.1) | 182.8 (112.8-166.7) | MD, −15.43 (−52.59 to 21.73) | .42 | MD, −21.0 (−56.32 to 14.31) | .24 | |
| No. | 43 | 44 | |||||
| Median (IQR) | 180.0 (133.3 to 200.0) | 166.7 (137.5 to 200.0) | |||||
Abbreviations: MAP, mean arterial pressure; MD, mean difference; OR, odds ratio; Pao2, partial pressure of arterial oxygen; Paco2, partial pressure of arterial carbon dioxide; RD, risk difference, SOFA, Sequential Organ Failure Assessment.
SI conversion factors: To convert glucose from mg/dL to mmol/L, multiply by 0.0555; lactate from mg/dL to mmol/L, multiply by 0.111.
The value of the unadjusted MD may not be the same as the difference in means presented between the groups (landiolol vs standard care). This is because the model was fitted to the observed values for each time point, whereas the means are calculated by first calculating the mean for each patient over time and then the mean of the means over all patients in each group.
Adjusted for age, sex, and baseline norepinephrine value.