| Characteristic . | Randomized to ICBC (n = 48), n (%) . | Randomized to IWBC (n = 49), n (%) . | Overall (n = 97), n (%) . |
|---|---|---|---|
| Demography | |||
| Age (years), median (IQR) | 0.9 (0.3–5.2) | 1.5 (0.3–4.0) | 1.2 (0.3–4.4) |
| Female | 12/48 (25.0%) | 22/49 (44.9%) | 34/97 (35.1%) |
| Body mass index, median (IQR) | 16.1 (14.2–17.9) | 15.6 (14.0–17.0) | 15.8 (14.2–17.5) |
| Body surface area (m2),a median (IQR) | 0.4 (0.3–0.8) | 0.5 (0.3–0.7) | 0.5 (0.3–0.7) |
| Procedure | |||
| Ross | 4/48 (8.3%) | 1/49 (2.0%) | 5/97 (5.2%) |
| Pulmonary pathway procedure | 6/48 (12.5%) | 5/49 (10.2%) | 11/97 (11.3%) |
| Ventricular septal defect ± atrial septal defect ± pulmonary artery debanding | 9/48 (18.8%) | 8/49 (16.3%) | 17/97 (17.5%) |
| Arterial switch ± ventricular septal defect | 2/48 (4.2%) | 2/49 (4.1%) | 4/97 (4.1%) |
| Tetralogy of Fallot repair | 4/48 (8.3%) | 8/49 (16.3%) | 12/97 (12.4%) |
| Atrioventricular valve repair/replacement | 3/48 (6.3%) | 4/49 (8.2%) | 7/97 (7.2%) |
| Atrioventricular septal defect | 8/48 (16.7%) | 7/49 (14.3%) | 15/97 (15.5%) |
| Double outlet right ventricle | 2/48 (4.2%) | 0/49 (0.0%) | 2/97 (2.1%) |
| Partial or total anomalous pulmonary venous drainage | 0/48 (0.0%) | 3/49 (6.1%) | 3/97 (3.1%) |
| Rastelli-type procedure | 1/48 (2.1%) | 2/49 (4.1%) | 3/97 (3.1%) |
| Subaortic stenosis repair | 6/48 (12.5%) | 4/49 (8.2%) | 10/97 (10.3%) |
| Otherb | 3/48 (6.3%) | 5/49 (10.2%) | 8/97 (8.2%) |
| RACHS score | |||
| 1–2 | 18/48 (37.5%) | 20/49 (40.8%) | 38/97 (39.2%) |
| 3+ | 30/48 (62.5%) | 29/49 (59.2%) | 59/97 (60.8%) |
| Preoperative left or right ventricular dysfunction | 8/31 (25.8%) | 4/31 (12.9%) | 12/62 (19.4%) |
| Bypass data | |||
| Duration of bypass (min),c median (IQR) | 101 (77.0–154.0) | 96 (67.0, 136.0) | 100 (69.5–146.0) |
| Duration of cross-clamp (min),c,d median (IQR) | 72 (43.0–137.0) | 69 (39.0–100.0) | 70 (43.0–108.0) |
| Mean core temperature while cross-clamp on (°C),e median (IQR) | 34.0 (32.3–34.8) | 34.8 (32.7–35.3) | 34.0 (32.5–35.0) |
| Cardioversion | 5/48 (10.4%) | 1/49 (2.0%) | 6/97 (6.2%) |
| Defibrillation | 3/48 (6.3%) | 2/49 (4.1%) | 5/97 (5.2%) |
| Ischaemic changes coming off CPB | 3/43 (7.0%) | 3/47 (6.4%) | 6/90 (6.7%) |
| Lowest haematocrit during surgery (%),a median (IQR) | 0.28 (0.26–0.29) | 0.27 (0.26–0.29) | 0.27 (0.26–0.29) |
| Modified ultrafiltration | 18/47 (38.3%) | 22/49 (44.9%) | 40/96 (41.7%) |
| Volume (ml), median (IQR) | 200 (180–210) | 235 (200–300) | 200 (190–260) |
| Cardioplegia | |||
| Intervention receivedc | 46/46 (100%) | 49/49 (100%) | 95/95 (100%) |
| Temperature of first infusion (°C),f median (IQR) | 4.0 (4.0–4.6) | 34.4 (34.0–35.0) | |
| Temperature of second infusion (°C),g median (IQR) | 4.0 (4.0–4.7) | 34.2 (34.0–35.0) | |
| Third infusion needed | 20/47 (42.6%) | 35/49 (71.4%) | 55/96 (57.3%) |
| Temperature of third infusion, if needed (°C),h median (IQR) | 4.0 (3.8–4.2) | 34.4 (34.0–35.1) | |
| Characteristic . | Randomized to ICBC (n = 48), n (%) . | Randomized to IWBC (n = 49), n (%) . | Overall (n = 97), n (%) . |
|---|---|---|---|
| Demography | |||
| Age (years), median (IQR) | 0.9 (0.3–5.2) | 1.5 (0.3–4.0) | 1.2 (0.3–4.4) |
| Female | 12/48 (25.0%) | 22/49 (44.9%) | 34/97 (35.1%) |
| Body mass index, median (IQR) | 16.1 (14.2–17.9) | 15.6 (14.0–17.0) | 15.8 (14.2–17.5) |
| Body surface area (m2),a median (IQR) | 0.4 (0.3–0.8) | 0.5 (0.3–0.7) | 0.5 (0.3–0.7) |
| Procedure | |||
| Ross | 4/48 (8.3%) | 1/49 (2.0%) | 5/97 (5.2%) |
| Pulmonary pathway procedure | 6/48 (12.5%) | 5/49 (10.2%) | 11/97 (11.3%) |
| Ventricular septal defect ± atrial septal defect ± pulmonary artery debanding | 9/48 (18.8%) | 8/49 (16.3%) | 17/97 (17.5%) |
| Arterial switch ± ventricular septal defect | 2/48 (4.2%) | 2/49 (4.1%) | 4/97 (4.1%) |
| Tetralogy of Fallot repair | 4/48 (8.3%) | 8/49 (16.3%) | 12/97 (12.4%) |
| Atrioventricular valve repair/replacement | 3/48 (6.3%) | 4/49 (8.2%) | 7/97 (7.2%) |
| Atrioventricular septal defect | 8/48 (16.7%) | 7/49 (14.3%) | 15/97 (15.5%) |
| Double outlet right ventricle | 2/48 (4.2%) | 0/49 (0.0%) | 2/97 (2.1%) |
| Partial or total anomalous pulmonary venous drainage | 0/48 (0.0%) | 3/49 (6.1%) | 3/97 (3.1%) |
| Rastelli-type procedure | 1/48 (2.1%) | 2/49 (4.1%) | 3/97 (3.1%) |
| Subaortic stenosis repair | 6/48 (12.5%) | 4/49 (8.2%) | 10/97 (10.3%) |
| Otherb | 3/48 (6.3%) | 5/49 (10.2%) | 8/97 (8.2%) |
| RACHS score | |||
| 1–2 | 18/48 (37.5%) | 20/49 (40.8%) | 38/97 (39.2%) |
| 3+ | 30/48 (62.5%) | 29/49 (59.2%) | 59/97 (60.8%) |
| Preoperative left or right ventricular dysfunction | 8/31 (25.8%) | 4/31 (12.9%) | 12/62 (19.4%) |
| Bypass data | |||
| Duration of bypass (min),c median (IQR) | 101 (77.0–154.0) | 96 (67.0, 136.0) | 100 (69.5–146.0) |
| Duration of cross-clamp (min),c,d median (IQR) | 72 (43.0–137.0) | 69 (39.0–100.0) | 70 (43.0–108.0) |
| Mean core temperature while cross-clamp on (°C),e median (IQR) | 34.0 (32.3–34.8) | 34.8 (32.7–35.3) | 34.0 (32.5–35.0) |
| Cardioversion | 5/48 (10.4%) | 1/49 (2.0%) | 6/97 (6.2%) |
| Defibrillation | 3/48 (6.3%) | 2/49 (4.1%) | 5/97 (5.2%) |
| Ischaemic changes coming off CPB | 3/43 (7.0%) | 3/47 (6.4%) | 6/90 (6.7%) |
| Lowest haematocrit during surgery (%),a median (IQR) | 0.28 (0.26–0.29) | 0.27 (0.26–0.29) | 0.27 (0.26–0.29) |
| Modified ultrafiltration | 18/47 (38.3%) | 22/49 (44.9%) | 40/96 (41.7%) |
| Volume (ml), median (IQR) | 200 (180–210) | 235 (200–300) | 200 (190–260) |
| Cardioplegia | |||
| Intervention receivedc | 46/46 (100%) | 49/49 (100%) | 95/95 (100%) |
| Temperature of first infusion (°C),f median (IQR) | 4.0 (4.0–4.6) | 34.4 (34.0–35.0) | |
| Temperature of second infusion (°C),g median (IQR) | 4.0 (4.0–4.7) | 34.2 (34.0–35.0) | |
| Third infusion needed | 20/47 (42.6%) | 35/49 (71.4%) | 55/96 (57.3%) |
| Temperature of third infusion, if needed (°C),h median (IQR) | 4.0 (3.8–4.2) | 34.4 (34.0–35.1) | |
Data missing for 1 patient (ICBC).
Other procedures were: ICBC group—double outlet right ventricle and partial anomalous pulmonary venous drainage repair, aortic root replacement, tricuspid valve repair and right ventricular myectomy. IWBC group—repair of double outlet right ventricle and atrioventricular septal defect and atrial switch (hemi-Mustard), tetralogy of Fallot and atrioventricular septal defect repair, mitral valve replacement and Ross-Konno, ventricular septal defect and Ebstein’s repair, pulmonary and tricuspid valve replacement.
Two patients (ICBC) withdrew prior to or during surgery.
Ranges (minimum–maximum): ICBC: 25–200 min, IWBC 16–292 min.
Data missing for 1 patient (IWBC).
Data missing for 6 patients (4 ICBC, 2 IWBC).
Data missing for 20 patients (13 ICBC, 7 IWBC).
Data missing for 2 patients (1 ICBC, 1 IWBC).
CPB: cardiopulmonary bypass; ICBC: intermittent cold blood cardioplegia; IQR: interquartile range; IWBC: intermittent warm blood cardioplegia; RACHS: Risk adjustment for Congenital Heart Surgery.
| Characteristic . | Randomized to ICBC (n = 48), n (%) . | Randomized to IWBC (n = 49), n (%) . | Overall (n = 97), n (%) . |
|---|---|---|---|
| Demography | |||
| Age (years), median (IQR) | 0.9 (0.3–5.2) | 1.5 (0.3–4.0) | 1.2 (0.3–4.4) |
| Female | 12/48 (25.0%) | 22/49 (44.9%) | 34/97 (35.1%) |
| Body mass index, median (IQR) | 16.1 (14.2–17.9) | 15.6 (14.0–17.0) | 15.8 (14.2–17.5) |
| Body surface area (m2),a median (IQR) | 0.4 (0.3–0.8) | 0.5 (0.3–0.7) | 0.5 (0.3–0.7) |
| Procedure | |||
| Ross | 4/48 (8.3%) | 1/49 (2.0%) | 5/97 (5.2%) |
| Pulmonary pathway procedure | 6/48 (12.5%) | 5/49 (10.2%) | 11/97 (11.3%) |
| Ventricular septal defect ± atrial septal defect ± pulmonary artery debanding | 9/48 (18.8%) | 8/49 (16.3%) | 17/97 (17.5%) |
| Arterial switch ± ventricular septal defect | 2/48 (4.2%) | 2/49 (4.1%) | 4/97 (4.1%) |
| Tetralogy of Fallot repair | 4/48 (8.3%) | 8/49 (16.3%) | 12/97 (12.4%) |
| Atrioventricular valve repair/replacement | 3/48 (6.3%) | 4/49 (8.2%) | 7/97 (7.2%) |
| Atrioventricular septal defect | 8/48 (16.7%) | 7/49 (14.3%) | 15/97 (15.5%) |
| Double outlet right ventricle | 2/48 (4.2%) | 0/49 (0.0%) | 2/97 (2.1%) |
| Partial or total anomalous pulmonary venous drainage | 0/48 (0.0%) | 3/49 (6.1%) | 3/97 (3.1%) |
| Rastelli-type procedure | 1/48 (2.1%) | 2/49 (4.1%) | 3/97 (3.1%) |
| Subaortic stenosis repair | 6/48 (12.5%) | 4/49 (8.2%) | 10/97 (10.3%) |
| Otherb | 3/48 (6.3%) | 5/49 (10.2%) | 8/97 (8.2%) |
| RACHS score | |||
| 1–2 | 18/48 (37.5%) | 20/49 (40.8%) | 38/97 (39.2%) |
| 3+ | 30/48 (62.5%) | 29/49 (59.2%) | 59/97 (60.8%) |
| Preoperative left or right ventricular dysfunction | 8/31 (25.8%) | 4/31 (12.9%) | 12/62 (19.4%) |
| Bypass data | |||
| Duration of bypass (min),c median (IQR) | 101 (77.0–154.0) | 96 (67.0, 136.0) | 100 (69.5–146.0) |
| Duration of cross-clamp (min),c,d median (IQR) | 72 (43.0–137.0) | 69 (39.0–100.0) | 70 (43.0–108.0) |
| Mean core temperature while cross-clamp on (°C),e median (IQR) | 34.0 (32.3–34.8) | 34.8 (32.7–35.3) | 34.0 (32.5–35.0) |
| Cardioversion | 5/48 (10.4%) | 1/49 (2.0%) | 6/97 (6.2%) |
| Defibrillation | 3/48 (6.3%) | 2/49 (4.1%) | 5/97 (5.2%) |
| Ischaemic changes coming off CPB | 3/43 (7.0%) | 3/47 (6.4%) | 6/90 (6.7%) |
| Lowest haematocrit during surgery (%),a median (IQR) | 0.28 (0.26–0.29) | 0.27 (0.26–0.29) | 0.27 (0.26–0.29) |
| Modified ultrafiltration | 18/47 (38.3%) | 22/49 (44.9%) | 40/96 (41.7%) |
| Volume (ml), median (IQR) | 200 (180–210) | 235 (200–300) | 200 (190–260) |
| Cardioplegia | |||
| Intervention receivedc | 46/46 (100%) | 49/49 (100%) | 95/95 (100%) |
| Temperature of first infusion (°C),f median (IQR) | 4.0 (4.0–4.6) | 34.4 (34.0–35.0) | |
| Temperature of second infusion (°C),g median (IQR) | 4.0 (4.0–4.7) | 34.2 (34.0–35.0) | |
| Third infusion needed | 20/47 (42.6%) | 35/49 (71.4%) | 55/96 (57.3%) |
| Temperature of third infusion, if needed (°C),h median (IQR) | 4.0 (3.8–4.2) | 34.4 (34.0–35.1) | |
| Characteristic . | Randomized to ICBC (n = 48), n (%) . | Randomized to IWBC (n = 49), n (%) . | Overall (n = 97), n (%) . |
|---|---|---|---|
| Demography | |||
| Age (years), median (IQR) | 0.9 (0.3–5.2) | 1.5 (0.3–4.0) | 1.2 (0.3–4.4) |
| Female | 12/48 (25.0%) | 22/49 (44.9%) | 34/97 (35.1%) |
| Body mass index, median (IQR) | 16.1 (14.2–17.9) | 15.6 (14.0–17.0) | 15.8 (14.2–17.5) |
| Body surface area (m2),a median (IQR) | 0.4 (0.3–0.8) | 0.5 (0.3–0.7) | 0.5 (0.3–0.7) |
| Procedure | |||
| Ross | 4/48 (8.3%) | 1/49 (2.0%) | 5/97 (5.2%) |
| Pulmonary pathway procedure | 6/48 (12.5%) | 5/49 (10.2%) | 11/97 (11.3%) |
| Ventricular septal defect ± atrial septal defect ± pulmonary artery debanding | 9/48 (18.8%) | 8/49 (16.3%) | 17/97 (17.5%) |
| Arterial switch ± ventricular septal defect | 2/48 (4.2%) | 2/49 (4.1%) | 4/97 (4.1%) |
| Tetralogy of Fallot repair | 4/48 (8.3%) | 8/49 (16.3%) | 12/97 (12.4%) |
| Atrioventricular valve repair/replacement | 3/48 (6.3%) | 4/49 (8.2%) | 7/97 (7.2%) |
| Atrioventricular septal defect | 8/48 (16.7%) | 7/49 (14.3%) | 15/97 (15.5%) |
| Double outlet right ventricle | 2/48 (4.2%) | 0/49 (0.0%) | 2/97 (2.1%) |
| Partial or total anomalous pulmonary venous drainage | 0/48 (0.0%) | 3/49 (6.1%) | 3/97 (3.1%) |
| Rastelli-type procedure | 1/48 (2.1%) | 2/49 (4.1%) | 3/97 (3.1%) |
| Subaortic stenosis repair | 6/48 (12.5%) | 4/49 (8.2%) | 10/97 (10.3%) |
| Otherb | 3/48 (6.3%) | 5/49 (10.2%) | 8/97 (8.2%) |
| RACHS score | |||
| 1–2 | 18/48 (37.5%) | 20/49 (40.8%) | 38/97 (39.2%) |
| 3+ | 30/48 (62.5%) | 29/49 (59.2%) | 59/97 (60.8%) |
| Preoperative left or right ventricular dysfunction | 8/31 (25.8%) | 4/31 (12.9%) | 12/62 (19.4%) |
| Bypass data | |||
| Duration of bypass (min),c median (IQR) | 101 (77.0–154.0) | 96 (67.0, 136.0) | 100 (69.5–146.0) |
| Duration of cross-clamp (min),c,d median (IQR) | 72 (43.0–137.0) | 69 (39.0–100.0) | 70 (43.0–108.0) |
| Mean core temperature while cross-clamp on (°C),e median (IQR) | 34.0 (32.3–34.8) | 34.8 (32.7–35.3) | 34.0 (32.5–35.0) |
| Cardioversion | 5/48 (10.4%) | 1/49 (2.0%) | 6/97 (6.2%) |
| Defibrillation | 3/48 (6.3%) | 2/49 (4.1%) | 5/97 (5.2%) |
| Ischaemic changes coming off CPB | 3/43 (7.0%) | 3/47 (6.4%) | 6/90 (6.7%) |
| Lowest haematocrit during surgery (%),a median (IQR) | 0.28 (0.26–0.29) | 0.27 (0.26–0.29) | 0.27 (0.26–0.29) |
| Modified ultrafiltration | 18/47 (38.3%) | 22/49 (44.9%) | 40/96 (41.7%) |
| Volume (ml), median (IQR) | 200 (180–210) | 235 (200–300) | 200 (190–260) |
| Cardioplegia | |||
| Intervention receivedc | 46/46 (100%) | 49/49 (100%) | 95/95 (100%) |
| Temperature of first infusion (°C),f median (IQR) | 4.0 (4.0–4.6) | 34.4 (34.0–35.0) | |
| Temperature of second infusion (°C),g median (IQR) | 4.0 (4.0–4.7) | 34.2 (34.0–35.0) | |
| Third infusion needed | 20/47 (42.6%) | 35/49 (71.4%) | 55/96 (57.3%) |
| Temperature of third infusion, if needed (°C),h median (IQR) | 4.0 (3.8–4.2) | 34.4 (34.0–35.1) | |
Data missing for 1 patient (ICBC).
Other procedures were: ICBC group—double outlet right ventricle and partial anomalous pulmonary venous drainage repair, aortic root replacement, tricuspid valve repair and right ventricular myectomy. IWBC group—repair of double outlet right ventricle and atrioventricular septal defect and atrial switch (hemi-Mustard), tetralogy of Fallot and atrioventricular septal defect repair, mitral valve replacement and Ross-Konno, ventricular septal defect and Ebstein’s repair, pulmonary and tricuspid valve replacement.
Two patients (ICBC) withdrew prior to or during surgery.
Ranges (minimum–maximum): ICBC: 25–200 min, IWBC 16–292 min.
Data missing for 1 patient (IWBC).
Data missing for 6 patients (4 ICBC, 2 IWBC).
Data missing for 20 patients (13 ICBC, 7 IWBC).
Data missing for 2 patients (1 ICBC, 1 IWBC).
CPB: cardiopulmonary bypass; ICBC: intermittent cold blood cardioplegia; IQR: interquartile range; IWBC: intermittent warm blood cardioplegia; RACHS: Risk adjustment for Congenital Heart Surgery.
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