Patient demography
| Thermic-1 | Thermic-2 | Overall | Total (n=200) | |||||
| Randomised to normothermic (n=28) | Randomised to hypothermic (n=31) | Randomised to normothermic (n=70) | Randomised to hypothermic (n=71) | Randomised to normothermic (n=98) | Randomised to hypothermic (n=102) | |||
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | ||
| Age | Median (IQR) | 7.5 (3.5, 10.6) | 4.3 (2.2, 11.5) | 2.3 (0.5, 5.2) | 2.9 (0.5, 6.0) | 3.3 (0.7, 7.6) | 3.5 (0.8, 6.8) | 3.4 (0.7, 7.3) |
| Males | 19/28 (68%) | 15/31 (48%) | 30/70 (43%) | 31/71 (44%) | 49/98 (50%) | 46/102 (45%) | 95/200 (48%) | |
| Height (cm)* | Median (IQR) | 124.5 (99.5, 131.5) | 106 (86.0, 140.3) | 85 (64.0, 104.0) | 89 (65.0, 108.0) | 95 (67.0, 125.0) | 96.5 (68.0, 115.0) | 95 (68.0, 123.0) |
| Weight (kg) | Median (IQR) | 23.4 (14.4, 32.0) | 16.4 (10.9, 39.9) | 10.6 (6.4, 17.4) | 12.5 (6.4, 18.7) | 13.1 (6.7, 24.7) | 13.9 (7.3, 22.6) | 13.6 (6.9, 23.4) |
| Body surface area (m2)† | Median (IQR) | 0.9 (0.6, 1.1) | 0.7 (0.5, 1.2) | 0.5 (0.3, 0.7) | 0.5 (0.3, 0.8) | 0.6 (0.3, 0.9) | 0.6 (0.4, 0.8) | 0.6 (0.3, 0.9) |
| Cardiac condition‡ | TOF | 0/28 (0%) | 0/31 (0%) | 9/70 (13%) | 12/71 (17%) | 9/98 (9%) | 12/102 (12%) | 21/200 (11%) |
| ASD | 11/28 (39%) | 10/31 (32%) | 16/70 (23%) | 17/71 (24%) | 27/98 (28%) | 27/102 (26%) | 54/200 (27%) | |
| TCPC | 0/28 (0%) | 0/31 (0%) | 1/70 (1%) | 0/71 (0%) | 1/98 (1%) | 0/102 (0%) | 1/200 (1%) | |
| PA reconstruction§ | 1/28 (4 %) | 1/31 (3%) | 2/70 (3%) | 3/71 (4%) | 3/98 (3%) | 4/102 (4%) | 7/200 (4%) | |
| VSD | 6/28 (21%) | 8/31 (26%) | 19/70 (27%) | 16/71 (23%) | 25/98 (26%) | 24/102 (24%) | 49/200 (25%) | |
| AVSD | 1/28 (4%) | 4/31 (13%) | 8/70 (11%) | 7/71 (10%) | 9/98 (9%) | 11/102 (11%) | 20/200 (10%) | |
| Other¶ | 16/28 (57 %) | 16/31 (52%) | 37/70 (53%) | 33/71 (46%) | 53/98 (54%) | 49/102 (48%) | 102/200 (51%) | |
| RACHS score | 1 | 8/28 (29%) | 7/31 (23%) | 8/70 (11%) | 12/71 (17%) | 16/98 (16%) | 19/102 (19%) | 35/200 (18%) |
| 2 | 18/28 (64%) | 20/31 (65%) | 31/70 (44%) | 39/71 (55%) | 49/98 (50%) | 59/102 (58%) | 108/200 (54%) | |
| 3 | 2/28 (7%) | 4/31 (13%) | 29/70 (41%) | 20/71 (28%) | 31/98 (32%) | 24/102 (24%) | 55/200 (28%) | |
| 4 | 0/28 (0%) | 0/31 (0%) | 2/70 (3%) | 0/71 (0%) | 2/98 (2%) | 0/102 (0%) | 2/200 (1%) | |
Further details are given in online supplementary table S2.
Thermic-1 normothermic (n=7): ASD and other (n=3), ASD and PA reconstruction (n=1), VSD and other (n=3).
Thermic-1 hypothermic (n=8): ASD and other (n=3), AVSD and other (n=1), VSD and other (n=4).
Thermic-2 normothermic (n=20): ASD and other (n=2), ASD and VSD (n=3), ASD and PA reconstruction (n=1), AVSD and other (n=1), PA reconstruction and other (n=1), TCPC and other (n=1), VSD and other (n=8), ASD and VSD and other (n=1), ASD and VSD and AVSD (n=1), VSD and multiple other procedures (n=1).
Thermic-2 hypothermic (n=15): ASD and other (n=2), ASD and VSD (n=2), AVSD and other (n=2), multiple other procedures (n=1), PA reconstruction and other (n=1), PA reconstruction and VSD (n=1), VSD and other (n=3), ASD and VSD and other (n=1), PA reconstruction and VSD and other (n=1), TOF and VSD and other (n=1).
Missing data:
*Three patients (Thermic-1 only: all normothermic).
†Three patients (Thermic-1 only: two normothermic, one hypothermic).
‡The collateral circulation in 4/102 patients was so high that CPB flow was reduced temporarily to achieve a bloodless field while operating and therefore body temperature was also lowered to make the CPB flow safe and reduce metabolism.
§Fifty patients had multiple cardiac conditions.
¶Details are given as footnotes and online supplementary tables.
TOF, tetralogy of fallot; ASD, atrial septal defect; TCPC, total cavopulmonary connection; PA, pulmonary artery; VSD, ventricular septal defect; AVSD, atrioventricular septal defect; RACHS, risk-adjusted congenital heart surgery.