| Treatment group (n = 50) | Control group (n = 45) | P- value |
---|---|---|---|
Age, months | Â | Â | 0.048* |
Median (Q1, Q3) | 4.7 (4.5, 5.1) | 5.2 (4.4, 6.2) |  |
Gender |  |  | 0.019†|
Female | 11Â (22.0%) | 20Â (44.4%) | Â |
Male | 39Â (78.0%) | 25Â (55.6%) | Â |
Race |  |  | 0.273†|
White | 36Â (72.0%) | 29Â (64.4%) | Â |
Black/African American | 3Â (6.0%) | 3Â (6.7%) | Â |
Asian | 3Â (6.0%) | 1Â (2.2%) | Â |
More than one | 3Â (6.0%) | 2Â (4.4%) | Â |
Unknown, none or no reported | 5Â (10.0%) | 10Â (22.2%) | Â |
Weight, kg | Â | Â | 0.538* |
Median (Q1, Q3) | 6.0 (5.6, 6.7) | 6.1 (5.7, 6.6) |  |
Height, cm | Â | Â | 0.552* |
Median (Q1, Q3) | 62.0 (60.0, 65.0) | 61.0 (59.0, 64.0) |  |
Heart Rate/Pulse, bpm |  |  | 0.232* |
Median (Q1, Q3) | 123.5 (115, 137) | 122 (110, 132) |  |
SBP, mmHg Median (Q1, Q3) | 95 (74.0, 131.0) | 94.5 (74.0, 173.0) | 0.544* |
DBP, mmHg Median (Q1, Q3) | 50.5 (28.0, 89.0) | 53.0 (29.0, 95.0) | 0.787* |
SBP at discharge, mmHg Median (Q1, Q3) | 96.5 (69.0, 138.0) | 94.0 (69.0, 135.0) | 0.069* |
DBP at discharge, mmHg Median (Q1, Q3) | 50.0 (37.0, 89.0) | 52.0 (34.0, 81.0) | 0.222* |
SPO2Â (%) | Â | Â | 0.590* |
Median (Q1, Q3) | 80.5 (77, 84) | 80.0 (78, 84) | Â |
Cardiac function as assessed by echocardiography | |||
FAC, % (n) | 48 | 45 | 0.963* |
Median (Q1, Q3) | 41.7 (37.1, 44.9) | 41.9 (38.1, 45.0) |  |
Circumferential Strain, % (n) | 43 | 39 | 0.463* |
Median (Q1, Q3) | -15.3 (-17.7, -11.9) | -16.4 (-18.9, -12.5) |  |
Longitudinal Strain, % (n) | 48 | 45 | 0.137* |
Median (Q1, Q3) | -14.5 (-17.0, -12.4) | -15.9 (-18.0, -13.4) |  |
Cardiac biomarkers | |||
Troponin-T, ng/mL (n) | 42 | 41 | 0.376* |
Median (Q1, Q3) | 0.025 (0.018, 0.039) | 0.024 (0.013, 0.038) |  |
Troponin-T, 3Â h post-surgery, ng/mL (n) Median (Q1, Q3) | 42 0.797 (0.136, 2.322) | 40 0.643 (0.155, 1.424) | 0.131* |
Troponin-T, 6Â h post-surgery, ng/mL (n) Median (Q1, Q3) | 46 0.666 (0.000, 1.763) | 39 0.583 (0.015) | 0.255* |
NT-Pro-BNP, pg/mL (n) | 48 | 43 | 0.450* |
Median (Q1, Q3) | 1296.0 (687.5, 3066.0) | 1200.0 (855.0, 2196.0) |  |
CRP, mg/L (n) | 49 | 42 | 0.105* |
Median (Q1, Q3) | 5.0 (2.9, 5.0) | 5.0 (2.5, 6.0) |  |
Liver/Renal Function | |||
ALT, U/L (n) | 48 | 42 | 0.420* |
Median (Q1, Q3) | 25.0 (19.1, 34.0) | 22.0 (17.0, 37.0) |  |
AST, U/L (n) | 48 | 42 | 0.938* |
Median (Q1, Q3) | 43.0 (36.0, 53.0) | 40.5 (36.0, 56.0) |  |
Alk Phosphatase, U/L (n) | 48 | 42 | 0.087* |
Median (Q1, Q3) | 269.5 (222.0, 333.5) | 237.0 (197.0, 309.0) |  |
Bilirubin, mg/dL (n) | 48 | 42 | 0.948* |
Median (Q1, Q3) | 0.4 (0.3, 0.5) | 0.4 (0.3, 0.6) |  |
Albumin, g/dL (n) | 48 | 43 | 0.529* |
Median (Q1, Q3) | 3.5 (3.2, 4.2) | 3.5 (3.1, 4.1) |  |
Total proteins, g/dL (n) | 48 | 41 | 0.211* |
Median (Q1, Q3) | 5.6 (5.3, 6.1) | 5.4 (5.0, 5.9) |  |
Creatinine, mg/dL (n) | 48 | 43 | 0.049* |
Median (Q1, Q3) | 0.2 (0.2, 0.3) | 0.2 (0.2, 0.2) |  |
BUN, mg/dL (n) | 48 | 43 | 0.503* |
Median (Q1, Q3) | 11.0 (8.0, 15.0) | 12.0 (8.0, 16.0) |  |
CBC w/Differential | |||
Hemoglobin, g/dL (n) | 49 | 45 | 0.365* |
Median (Q1, Q3) | 15.1 (13.9, 16.1) | 15.6 (14.2, 16.3) |  |
Hematocrit, % (n) | 49 | 45 | 0.386* |
Median (Q1, Q3) | 46.1 (42.9, 50.0) | 46.6 (43.9, 50.6) |  |
WBCs, (n) | 49 | 45 | 0.671* |
Median (Q1, Q3) | 7.2 (5.7, 8.6) | 7.2 (5.8, 8.9) |  |
Platelets, (n) | 49 | 45 | 0.379* |
Median (Q1, Q3) | 332.0 (278.0, 390.0) | 303.0 (264.0, 360.0) |  |
Lymphocytes, (n) | 47 | 45 | 0.046* |
Median (Q1, Q3) | 3.5 (2.4, 5.6) | 3.1 (2.1, 4.1) |  |
Type of stage I and stage II palliation surgery | |||
Stage I surgery type |  |  | 0.049†|
Norwood procedure with mBT shunt | 8 (16.0%) | 5 (11.1%) |  |
Norwood procedure with nonvalved RV- PA shunt | 22 (44.0%) | 32 (71.1%) | |
Norwood procedure with valved RV-PA shunt | 17 (34.0%) | 5 (11.1%) | |
Hybrid Procedure | 2 (4.0%) | 1 (2.2%) | |
Other (specify) | 1 (2.0%) | 2 (4.4%) | |
Stage II surgery type |  |  | 0.375†|
Glenn procedure | 44 (88.0%) | 42 (93.3%) |  |
Hemi-Fontan | 6Â (12.0%) | 3Â (6.7%) | Â |
Stage II Surgery Details | |||
Cardio-pulmonary bypass time, min (n) | 48 | 44 | 0.024* |
Median (Q1, Q3) | 64.0 (38.0, 91.0) | 83.0 (51.0, 113.5) |  |
Aortic cross-clamp time, min (n) | 19 | 22 | 0.732* |
Median (Q1, Q3) | 28.0 (0.0, 50.0) | 3.0 (0.0, 53.0) |  |