Momeni 2011.
Methods | Randomised controlled trial. | |
Participants | 41 (20 intervention, 21 control), aged under five years, undergoing corrective surgery for congenital heart defects using CPB and in need of inotropic support. | |
Interventions | Intervention: 0.05 µg/kg/min of levosimendan, started at onset of CPB, allowed to be doubled, for a maximum of 48 hours. Control: 0.4 µg/kg/min of milrinone, started at onset of CPB, allowed to be doubled, for a maximum of 48 hours. |
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Outcomes | Recorded until 48 hours after admission to paediatric ICU: 1. Lactate level at four hours postoperatively. 2. Biologic markers and haemodynamic data (heart rate, mean arterial pressure, lactate, difference between arterial and mixed venous oxygen saturations, troponin, creatinine, alanine aminotransferase, aspartate aminotransferase). |
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Notes | One patient (control group) excluded who did not receive study medication because of modification of the surgical plan, two patients (1 intervention group, 1 control group) excluded because they required extracorporeal membrane oxygenation at the end of CPB, two patients (1 intervention group, 1 control group) excluded because of intraoperative death. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random code. |
Allocation concealment (selection bias) | Low risk | Allocation code was concealed in an envelope opened by the study nurse in charge of preparing the medication. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Syringes and tubing system covered with aluminium foil, both drugs administered at same infusion rates. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Syringes and tubing system covered with aluminium foil, both drugs administered at same infusion rates. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Two patients (1 intervention group, 1 control group) excluded because they required extracorporeal membrane oxygenation at the end of CPB, two patients (1 intervention group, 1 control group) excluded because of intraoperative death. |
Selective reporting (reporting bias) | Low risk | No incomplete reporting suspected. |
Other bias | Low risk | No other bias suspected. |