Table 2.
Secondary Outcomes for Dopamine Strategy
| Endpoint* | N missing before imputation |
Placebo | Dopamine | Treatment difference, dopamine – placebo (95% CI) |
P value† | Interaction P Value |
|---|---|---|---|---|---|---|
| Weight Change (lbs) | 0.0001 | |||||
| EF ≤ 40% | 9 | −5.1 (−10.0, −2.4) | −8.9 (−13, −4.0) | −2.8 (−5.1, −0.5) | 0.0161 | |
| EF > 40% | 8 | −9.4 (−14.0, −5.1) | −6.0 (−9.0, −1.5) | 4.6 (1.4, 7.9) | 0.0056 | |
| 72-hr Na Excretion (mmol) | 0.0094 | |||||
| EF ≤ 40% | 30 | 445 (308, 672) | 536 (328, 763) | 65 (−33, 163) | 0.20 | |
| EF > 40% | 20 | 548 (350, 720) | 396 (261, 546) | −150 (−280, −20) | 0.0235 | |
| AUC VAS Change | 0.0564 | |||||
| EF ≤ 40% | 8 | 4860 (3698, 5616) | 4547 (3728, 5615) | 71 (−273, 416) | n/a | |
| EF > 40% | 7 | 5084 (4366, 5863) | 4651 (3505, 5412) | −468 (−884, −51) | n/a | |
| NT-proBNP Change (pg/mL) | 0.16 | |||||
| EF ≤ 40% | 19 | −1611 (−3764, −175) | −2698 (−5162, −710) | −772 (−1838, 293) | n/a | |
| EF > 40% | 17 | −706 (−1531, −95) | −585 (−2264, 497) | 252 (−929, 1433) | n/a | |
| Creatinine Change (mg/dL) | 0.28 | |||||
| EF ≤ 40% | 19 | 0.04 (−0.13, 0.24) | 0.02 (−0.29, 0.25) | −0.06 (−0.19, 0.08) | n/a | |
| EF > 40% | 17 | −0.05 (−0.22, 0.11) | −0.03 (−0.26, 0.21) | 0.07 (−0.09, 0.23) | n/a | |
|
Odds ratio for dopamine v. placebo (95% CI) |
||||||
| Treatment failure at 72 hr (c=0.61) | 0.0190 | |||||
| EF ≤ 40% | 4 | 28/75 (37.3%) | 21/71 (29.6%) | 0.7 (0.4, 1.4) | 0.32 | |
| EF > 40% | 5 | 4/40 (10.0%) | 13/44 (29.5%) | 3.8 (1.1, 12.8) | 0.0327 | |
| CRS Incidence (c=0.67) | 0.0532 | |||||
| EF ≤ 40% | 13 | 20/71 (28.2%) | 14/66 (21.2%) | 0.7 (0.3, 1.5) | n/a | |
| EF > 40% | 12 | 4/39 (10.3%) | 9/38 (23.7%) | 3.1 (0.8, 11.4) | n/a | |
|
Hazard ratio for dopamine v. placebo (95% CI) |
||||||
| Death at 60 d (c=0.69) | 0.0053 | |||||
| EF ≤ 40% | 0 | 10/76 (13.7%) | 2/74 (2.8%) | 0.2 (0.04, 0.9) | 0.0328 | |
| EF > 40% | 0 | 2/43 (4.8%) | 8/46 (18.2%) | 4.2 (0.9, 19.8) | 0.0696 | |
| Death at 180 d (c=0.63) | 0.0025 | |||||
| EF ≤ 40% | 0 | 19/76 (26.5%) | 9/74 (12.7%) | 0.4 (0.2, 0.9) | 0.0323 | |
| EF > 40% | 0 | 5/43 (11.9%) | 14/46 (29.5%) | 3.1 (1.1, 8.6) | 0.0306 | |
| Death or HF ReHsp at 60d (c=0.59) | 0.0173 | |||||
| EF ≤ 40% | 2 | 22/75 (27.8%) | 16/73 (22.9%) | 0.7 (0.4, 1.3) | 0.23 | |
| EF > 40% | 3 | 7/42 (16.9%) | 16/44 (37.3%) | 2.6 (1.1, 6.2) | 0.0379 |
Data are median (25th, 75th percentile) or n/n with data (%) unless noted. Continuous endpoints use multiple imputation data and categorical variables use non-missing data.
Independent variables included in each model are EF category, randomized treatment, and the EF category-by-treatment interaction. In addition, models for change in weight, VAS, NT-proBNP, and creatinine also adjusted for the baseline value. Baseline creatinine was used for adjustment in the model for cardiorenal syndrome over 72 hours. The C-index is shown in parentheses for the binary and time to event endpoints.
P-values for treatment effects within EF categories are only shown if there is a significant interaction.
Abbreviations: AUC VAS, Area under the curve at 72 hours for Global Well Being Visual Analog Score; CRS, Cardiorenal Syndrome; d, day; HF, heart failure; hr, hour; ReHsp, re-hospitalization