| Methods | Randomised controlled trial. | |
| Participants | 63 (32 intervention, 31 control) neonates undergoing risk‐adjusted classification for congenital heart surgery (RACHS) 3 and 4 procedures | |
| Interventions | Intervention: continuous infusion of 0.1 µg/kg/min levosimendan for 72 hours added to standard inotropic support, started while weaning from CPB. Control: standard post‐CPB inotrope infusion (milrinone 0.75 µg/kg/min and dopamine 5 to 10 µg/kg/min, adrenaline 0.05 to 0.3 µg/kg/min if necessary). |
|
| Outcomes | Recorded until 72 hours postoperatively: 1. Incidence of LCOS (defined as tachycardia (heart rate > 170 beats/min), oliguria (urine output < 0.5 mL/kg/h), cold extremities (peripheral temperature < 27°C), with or without at least 30% difference in arterial to mixed venous oxygen saturation or metabolic acidosis (an increase in base deficit of greater than 4 or an increase in lactate of more than 2 mg/dL) on two successive blood gas measurements, cardiac arrest, need for extracorporeal membrane oxygenation 2. Lactate, heart rate, mean arterial pressure, inotropic score, diuresis, need for peritoneal dialysis, mixed venous oxygen saturation, brain natriuretic peptide (BNP), number of ventilation days, paediatric cardiac ICU length of stay and survival, side effects |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computerised random‐generation program. |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes containing the allocation group opened by a nurse in charge of preparing the infusions. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes listed in the methods section reported. |
| Selective reporting (reporting bias) | Low risk | No incomplete reporting suspected. |
| Other bias | Low risk | No other bias suspected. |
ICU = intensive care unit
LCOS = low cardiac output syndrome