Comparing Two Medications to Improve Heart Function after Tetralogy of Fallot Surgery

The Efficacy and safety of intravenous levosimendan compared with milrinone in preventing low cardiac output after corrective cardiac surgery in Tetralogy of fallot

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055845

Enrollment

Registered

2023-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q213- Tetralogy of Fallot

Interventions

Intervention1: Milrinone: intravenous administration of 30 mcg/kg loading dose followed by 0.5 mcg/kg/min infusion for 48 hours Control Intervention1: LEVOSIMENDAN: intravenous administration of 12 mc

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Patients admitted to the cardiac surgery intensive care after corrective cardiac surgery for tetralogy of Fallot will be included in the study

Exclusion criteria

Exclusion criteria: 1. TOF with other congenital cardiac anomalies 2. History of anaphylactic reaction to levosimendan or milrinone 3. Pre-operative renal impairment. 4. Pre-operative hepatic impairment.

Design outcomes

Primary

Measure	Time frame
To study the efficacy and safety of intravenous levosimendan compared with milrinone in preventing/managing low cardiac output syndrome by evaluating below given components of LCOS 1.LCOS 2.Arrhythmias in both milrinone and levosimendan : SVT, Ectopic atrial tachycardias, AF, Accelerated junctional rhytms, JET,VT and VF Timepoint: post operative period at interval of 0,6,12,18,24,36 and 48 hours after shifting to CHICU	—

Measure

Time frame

To study the efficacy and safety of intravenous levosimendan compared with milrinone in preventing/managing low cardiac output syndrome by evaluating below given components of LCOS 1.LCOS 2.Arrhythmias in both milrinone and levosimendan : SVT, Ectopic atrial tachycardias, AF, Accelerated junctional rhytms, JET,VT and VF Timepoint: post operative period at interval of 0,6,12,18,24,36 and 48 hours after shifting to CHICU

—

Secondary

Measure	Time frame
Post repair evaluation of right ventricular restrictive physiology by measuring end-diastolic forward flow in the pulmonary artery (PA) by Doppler echocardiography,Stroke volume (SV), cardiac index. Tricuspid and mitral inflow E/A values,Direction of PFO shunt,RVOT to pulmonary artery pressure gradient Timepoint: Post CPB TEE,POD 1,POD 2,POD 3;Rate pressure index during inodilator infusion Timepoint: post operative period at interval of 0,6,12,18,24,36 and 48 hours after shifting to CHICU ;Length of intensive care unit (ICU) stay. Timepoint: in days;Length of hospital stay. Timepoint: Days;Duration of mechanical ventilationTimepoint: hours;Duration of chest drain.Timepoint: Hours;Vasoactive-Inotrope score. Number of patients requiring mechanical circulatory support -ECMOTimepoint: not applicable	—

Measure

Time frame

Post repair evaluation of right ventricular restrictive physiology by measuring end-diastolic forward flow in the pulmonary artery (PA) by Doppler echocardiography,Stroke volume (SV), cardiac index. Tricuspid and mitral inflow E/A values,Direction of PFO shunt,RVOT to pulmonary artery pressure gradient Timepoint: Post CPB TEE,POD 1,POD 2,POD 3;Rate pressure index during inodilator infusion Timepoint: post operative period at interval of 0,6,12,18,24,36 and 48 hours after shifting to CHICU ;Length of intensive care unit (ICU) stay. Timepoint: in days;Length of hospital stay. Timepoint: Days;Duration of mechanical ventilationTimepoint: hours;Duration of chest drain.Timepoint: Hours;Vasoactive-Inotrope score. Number of patients requiring mechanical circulatory support -ECMOTimepoint: not applicable

—

Countries

India

Contacts

Public ContactASPARI MAHAMMAD AZEEZ

Sree Chitra Tirunal Institute for Medical Sciences and Technology,,TRIVANDRUM

unnikp@gmail.com9446177521

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026