Health Condition 1: Q219- Congenital malformation of cardiacseptum, unspecified Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Inhaled Milrinone: 50 mcg/kg drug as single dose nebulization through endotracheal tube in postoperative period after shifting to recovery
Control Intervention1: Inhaled Levosimendan: 2
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Congenital intracardiac left to right shunt complicated by Pulmonary artery hypertension (mean pulmonary artery pressure more than 20mm Hg as found during right heart catheterization) scheduled for surgical correction under Cardiopulmonary bypass
Exclusion criteria
Exclusion criteria: 1. refusal by guardians to give consent for the participation of their wards in the study 2. association with right-to-left shunts 3. history of previous cardiac surgery 4. heart failure (defined as failure of pumping function and manifested by dyspnea, tachypnea, chest wheezes, pulmonary edema, hepatomegaly, lower limb edema, and congested neck veins) preoperative inotropic support 5. hypersensitivity to Levosimendan and Milrinone 6. associated with Atrial Fibrillation 7. Re-exploration in ICU due to bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary Artery Systolic PressureTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8 T0 after shifting to ICU pre inhalation T1 post inhalation T2 30 minutes of ICU stay T3 1 hour of ICU stay T4 2 hours of ICU stay T5 4 hours of ICU stay T6 6 hours of ICU stay T7 12 hours of ICU stay T8 24 hours of ICU stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Central Venous PressureTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Heart RateTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Left Ventricular Ejection FractionTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Mean Arterial PressureTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Oxygen SaturationTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Right ventricular fractional area changeTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;TR Jet VelocityTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Tricuspid annular plane systolic excursionTimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8;Tricuspid STimepoint: Baseline, T0, T1, T2, T3, T4, T5, T6, T7, T8 | — |
Countries
India
Contacts
Public ContactSAURAV DAS
Institute of Post Graduate Medical Education and Research
Outcome results
None listed