Table 1:
Summary of Study Cohort.
| Whole cohort |
CYP3A5 normal metabolizers |
CYP3A5 intermediate metabolizers | CYP3A5 poor metabolizers |
CYP3A4
*1/*1 |
CYP3A4
*1/*1G |
CYP3A4
*1G/*1G |
|
|---|---|---|---|---|---|---|---|
|
|
|||||||
| N | 434 | 10 | 76 | 348 | 311 | 90 | 33 |
| Male sex | 226 (52%) | 6 (60%) | 32 (42%) | 188 (54%) | 166 (53%) | 44 (49%) | 16 (48%) |
| Weight at enrollment (kg) | 7.7 [5.3, 16.9] {1.9, 138.0} |
14.2 [6.7, 17.5] {3.4, 37.8} |
7.6 [5.1, 15.8] {2.1, 82.3} |
7.7 [5.3, 17.0] {1.9, 138.0} |
7.8 [5.3, 17.8] {1.9, 138.0} |
7.6 [5.5, 13.6] {2.1, 102.7} |
9.2 [4.6, 17.1] {2.8, 82.3} |
| Age at enrollment (months) | 9.0 [3.8, 58.5] {0.1, 270.9} |
41.1 [5.5, 43.9] {0.4, 126.9} |
8.2 [3.8, 50.6] {0.1, 232.3} |
9.0 [3.8, 59.4] {0.1, 270.9} |
8.9 [3.8, 61.7] {0.1, 270.9} |
8.2 [4.2, 37.2] {0.1, 246.2} |
18.3 [4.0, 62.8] {0.2, 214.1} |
| Race | |||||||
| White | 357 (82.3%) | 0 (0.0%) | 46 (60.5%) | 311 (89.4%) | 292(94.9%) | 59 (65.6%) | 6 (18.2%) |
| Black | 52 (12.0%) | 10 (100%) | 24 (31.6%) | 18 (5.2%) | 7 (2.3%) | 20 (22.2%) | 25 (75.8%) |
| Asian | 6 (1.4%) | 0 (0.0%) | 0 (0.0%) | 6 (1.7%) | 3 (1.0%) | 3 (3.3%) | 0 (0.0%) |
| American Indian or Alaska Native | 2 (0.5%) | 0 (0.0%) | 0 (0.0%) | 2 (0.5%) | 2 (0.6%) | 0 (0.0%) | 0 (0.0%) |
| Other | 6 (1.4%) | 0 (0.0%) | 2 (2.6%) | 4 (1.1%) | 2 (0.6%) | 3 (3.3%) | 1 (3.0%) |
| Unknown | 11 (2.5%) | 0 (0.0%) | 4 (5.2%) | 7 (2.0%) | 5 (1.6%) | 5 (5.6%) | 1 (3.0%) |
| Cardiac bypass time (hours) | 1.7 [1.1, 2.4] {0.0, 7.1} |
1.4 [1.0, 1.8] {0.0, 3.2} |
1.6 [1.0, 2.2] {0.0, 5.8} |
1.7 [1.2, 2.5] {0.0, 7.1} |
1.7 [1.1, 2.4] {0.0, 6.2} |
1.8 [1.2, 2.7] {0.0, 7.1} |
1.3 [0.7, 1.6] {0.0, 4.1} |
| Length of ICU stay (days) | 3 [2, 6] {0, 119} |
3 [1, 4] {1, 119} |
3 [2, 4] {1, 54} |
3 [2, 6] {0, 87} |
3 [2, 6] {0, 79} |
3 [2, 5] {1, 87} |
3 [2, 5] {1, 119} |
| STAT category | |||||||
| 1 | 164 (37.8%) | 4 (40.0%) | 28 (36.8%) | 132 (37.9%) | 120(38.6%) | 30 (33.3%) | 14 (42.4%) |
| 2 | 124 (28.6%) | 3 (30.0%) | 24 (31.6%) | 97 (27.9%) | 78 (25.1%) | 33 (36.7%) | 13 (39.4%) |
| 3 | 56 (12.9%) | 2 (20.0%) | 10 (13.2%) | 44 (12.6%) | 42 (13.5%) | 12 (13.3%) | 2 (6.1%) |
| 4 | 74 (17.1%) | 1 (10.0%) | 10 (13.2%) | 63 (18.1%) | 59 (19.0%) | 12 (13.3%) | 3 (9.1%) |
| 5 | 16 (3.7%) | 0 (0.0%) | 4 (5.3%) | 12 (3.4%) | 12 (3.9%) | 3 (3.3%) | 1 (3.0%) |
| CYP3A4*1G | |||||||
| 0 | 311 (71.7%) | ||||||
| 1 | 90 (20.7%) | ||||||
| 2 | 33 (7.6%) | ||||||
| CYP3A5*6 | |||||||
| 0 | 411 (94.7%) | ||||||
| 1 | 21 (4.8%) | ||||||
| 2 | 2 (0.5%) | ||||||
| CYP3A5*3 | |||||||
| 0 | 22 (5.1%) | ||||||
| 1 | 77 (17.7%) | ||||||
| 2 | 335 (77.2%) | ||||||
| CYP3A5 metabolizer status | |||||||
| Normal | 10 (2.3%) | ||||||
| Intermediate | 76 (17.5%) | ||||||
| Poor | 348 (80.2%) | ||||||
| ABCB1 rs1045642 | |||||||
| GG | 121 (27.8%) | ||||||
| AG | 213 (49.1%) | ||||||
| AA | 100 (23.0%) | ||||||
| Fentanyl blood concentrations per individual | 4 [3, 5] {1, 30} |
||||||
| Fentanyl blood concentration (ng/mL) | 0.25 [0.06, 1.31] {0.00, 34.25} |
||||||
| Fentanyl dosing events per individual | 7 [5, 11] {1, 56} |
||||||
Summary statistics are presented as count (percent) for categorical variables, and median [interquartile range] {range} for continuous variables. Selected covariates are also tabulated according to CYP3A5 metabolizer status and CYP3A4*1G variants. ICU, intensive care unit; STAT, Society of Thoracic Surgery–European Association for Cardio-Thoracic Surgery Congenital Heart Surgery Mortality Score.