CTRI/2023/07/055845.

Study name	The efficacy and safety of intravenous levosimendan compared with milrinone in preventing low cardiac output after corrective cardiac surgery in tetralogy of fallot
Methods	Randomised, single‐centre, parallel‐group, double‐blind clinical trial
Participants	50 patients aged 0 to 12 years admitted to cardiac surgery intensive care after corrective cardiac surgery for tetralogy of fallot, excluding patients with tetralogy of fallot and other congenital cardiac anomalies, patients with history of anaphylactic reaction to levosimendan or milrinone, with preoperative renal or hepatic impairment
Interventions	Intervention: milrinone; intravenous administration of 30 μg/kg loading dose followed by 0.5 μg/kg/min infusion for 48 hours Control: levosimendan; intravenous administration of 12 μg/kg loading dose followed by 0.1 μg/kg/min infusion for 48 hours
Outcomes	Aim: to study the efficacy and safety of intravenous levosimendan compared with milrinone in preventing/managing low cardiac output syndrome by evaluating the components of LCOS given below Primary outcome(s) LCOS Arrhythmias in both milrinone and levosimendan: SVT, ectopic atrial tachycardias, AF, accelerated junctional rhytms, JET, VT, and VF Time point for the primary outcomes: postoperative period at intervals of 0, 6, 12, 18, 24, 36, and 48 hours after shifting to CHICU
Starting date	Not recruiting yet, ethics review approved 30 June 2023
Contact information	Contact: Aspari Mahammad Azeez Email: unnikp@gmail.com
Notes	Funding source: Sree Chitra Tirunal Institute for Medical Sciences and Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011 Declarations of interest: not available