Table 1.
Study population baseline demographic and surgical characteristics
| Characteristics | Levosimendan group (n = 94) | Placebo group (n = 93) | p value |
|---|---|---|---|
| Age (months)a | 5 (2,11) | 7 (2,16) | 0.318 |
| Gender, female, n (%) | 42 (44.7%) | 41 (44.1%) | 1.000 |
| BMI (kg/m2) | 14.83 ± 2.21 | 14.76 ± 2.13 | 0.870 |
| BSA (m2) | 0.36 ± 0.17 | 0.39 ± 0.19 | 0.248 |
| RACHS classification, n (%)* | 0.146 | ||
| RACHS 2 | 53 (63.1%) | 67 (72.0%) | |
| RACHS 3 | 21 (25.0%) | 11 (11.8%) | |
| RACHS 4 | 9 (10.7%) | 13 (14.0%) | |
| RACHS 5 | 1 (1.2%) | 2 (2.2%) | |
| Down’s syndrome, n (%) | 3 (3.2%) | 2 (2.2%) | 0.660 |
| CPB (min) | 81 ± 34 | 84 ± 30 | 0.479 |
| Cross-clamp (min) | 46 ± 23 | 51 ± 22 | 0.163 |
Data are means ± standard deviation (SD) for continuous variables and number of subjects (n) and percentage (%) for categorical variables
BSA body surface area, RACHS Risk Adjustment for Congenital Heart Surgery, CPB cardiopulmonary bypass, BMI body mass index
aData are medians [Q1, Q3]
*RACHS classification was used to divide surgical procedures for congenital heart diseases into six categories of increasing predicted operative risk. The greater the score, the higher the risk associated with the procedure