A Study Comparing Inhaled and Intravenous Medicines to Help Children Safely Come Off the Heart-Lung Machine After Heart Surgery.

COMPARISON OF INHALED MILRINONE OR INHALED LEVOSIMENDAN VERSUS INTRAVENOUS MILRINONE FOR FACILITATING WEANING FROM CARDIOPULMONARY BYPASS IN CHILDREN WITH LEFT-TO-RIGHT SHUNTS: A DOUBLE-BLIND RANDOMIZED CONTROLLED STUDY - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106266

Enrollment

120

Registered

2026-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: Q219- Congenital malformation of cardiacseptum, unspecified

Interventions

Intervention1: group M: Group M: During rewarming, a bolus dose of Normal saline (50 g/kg) will be administered in the pump, followed by a continuous intravenous infusion at 0.5 g/kg/min. Inhaled mi

Eligibility

Inclusion criteria

Inclusion criteria: Patients, up to 18 years of age, with congenital left-to-right intracardiac shunt scheduled for surgical correction under cardiopulmonary bypass.

Exclusion criteria

Exclusion criteria: Weight less than 10 kg Refusal of consent by legal guardians Presence of right to left cardiac shunts or heart failure History of previous cardiac surgery Requirement for preoperative inotropic support Known hypersensitivity or allergic reaction to Levosimendan or Milrinone Presence of atrial fibrillation

Design outcomes

Primary

Measure	Time frame
1.Time taken to wean off from CPB in minutes (measured from the start of rewarming to CPB-off time). 2.Pulmonary artery pressures (PAP) in mm Hg at predefined time points. 3.Cardiac index, stroke volume index, systemic vascular resistance index, ejection fraction at predefined time points in the three groups (inhaled levosimendan, inhaled milrinone and intravenous milrinone). Timepoint: T0 : After induction before going on CPB (Baseline) T1: On resumption of ventilation in all three groups (before nebulisation). T2: Before coming off CPB in all 3 groups (after nebulisation). T3: 10 minutes after coming off CPB (after stabilization of haemodynamics and before protamine administration). T4: 10 minutes after protamine administration.	—

Measure

Time frame

1.Time taken to wean off from CPB in minutes (measured from the start of rewarming to CPB-off time). 2.Pulmonary artery pressures (PAP) in mm Hg at predefined time points. 3.Cardiac index, stroke volume index, systemic vascular resistance index, ejection fraction at predefined time points in the three groups (inhaled levosimendan, inhaled milrinone and intravenous milrinone). Timepoint: T0 : After induction before going on CPB (Baseline) T1: On resumption of ventilation in all three groups (before nebulisation). T2: Before coming off CPB in all 3 groups (after nebulisation). T3: 10 minutes after coming off CPB (after stabilization of haemodynamics and before protamine administration). T4: 10 minutes after protamine administration.

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Secondary

Measure	Time frame
RV function assessed by TEE. (PASP, TAPSE, S ), Inotropic Score (IS) & hemodynamic parameters (HR, MAP, CVP & SpO2) at pre-defined time pointsTimepoint: RV 0: After induction before going on CPB (Baseline) along with T0 RV1: On resumption of ventilation in all three groups (before nebulization) along with T1 RV2: After nebulization (before coming off CPB) along with T2 RV3: 10 minutes after coming off CPB before protamine (after stabilization of haemodynamics in all three groups, along with T3 RV 4: 10 minutes after protamine along with T4 ; The duration of ventilation & length of stay in the intensive care unit.Timepoint: duration of ventilation in days; length of stay in intensive care unit is total number of days in icu before being shifted to a step down unit; Rescue therapy (Yes/NO).Timepoint: Rescue Therapy: Intravenous milrinone (continuous infusion at 0.5 g/kg/min) if the PA pressure continues to be high with deterioration in RV function & difficulty in coming off bypass.; To assess the incidence of related complications such as arrhythmias, re-operations, & low cardiac output syndrome.Timepoint: to be assessed till the patient stays in the intensive care unit before being shifted to a step down unit.	—

Measure

Time frame

RV function assessed by TEE. (PASP, TAPSE, S ), Inotropic Score (IS) & hemodynamic parameters (HR, MAP, CVP & SpO2) at pre-defined time pointsTimepoint: RV 0: After induction before going on CPB (Baseline) along with T0 RV1: On resumption of ventilation in all three groups (before nebulization) along with T1 RV2: After nebulization (before coming off CPB) along with T2 RV3: 10 minutes after coming off CPB before protamine (after stabilization of haemodynamics in all three groups, along with T3 RV 4: 10 minutes after protamine along with T4 ; The duration of ventilation & length of stay in the intensive care unit.Timepoint: duration of ventilation in days; length of stay in intensive care unit is total number of days in icu before being shifted to a step down unit; Rescue therapy (Yes/NO).Timepoint: Rescue Therapy: Intravenous milrinone (continuous infusion at 0.5 g/kg/min) if the PA pressure continues to be high with deterioration in RV function & difficulty in coming off bypass.; To assess the incidence of related complications such as arrhythmias, re-operations, & low cardiac output syndrome.Timepoint: to be assessed till the patient stays in the intensive care unit before being shifted to a step down unit.

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Countries

India

Contacts

Public ContactDr Sanjula Virmani

Govind Ballabh Pant Institute of Post graduate Medical Education and Research

drsanjulavirmani@yahoo.co.in8847255674

Outcome results

None listed

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