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Comparing drugs dobutamine and milirinone in preventing low cardiac output syndrome in VSD children undergoing surgery

Comparison of the efficacy of Dobutamine versus Milrinone in preventing low cardiac output syndrome during post operative period in children with ventricular septal defect undergoing surgical repair: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094845
Enrollment
44
Registered
2025-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: Q210- Ventricular septal defect

Interventions

Intervention1: Milrinone: Patients will receive a continuous intravenous infusion of milrinone at an initial rate of 0.75 microgram per kg per min intraoperatively and will be continued till 24 hours

Sponsors

ANINDYA A
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All children aged 10 years or below diagnosed with moderate to large ventricular septal defects (VSD) who are planned for surgical patch closure. 2.Children with isolated VSD or VSD associated with additional minor congenital cardiac anomalies (e.g., small atrial septal defect, patent foramen ovale, mild valvular abnormalities, Patent ductus arteriosus (PDA)), provided that VSD is the principal lesion requiring surgical intervention.

Exclusion criteria

Exclusion criteria: Children presenting with cardiogenic shock with hypotension requiring inotropic support in the preoperative period. Patients with significant residual cardiac lesions identified postoperatively. Patients requiring extracorporeal membrane oxygenation during the postoperative period.

Design outcomes

Primary

MeasureTime frame
To Compare the efficacy of dobutamine versus milrinone in preventing low cardiac output syndrome in children aged less than and equal to 10 years undergoing surgical repair for ventricular septal defect. Patient will be followed till 48 hours of post-operative period.Timepoint: One year hospital based study—

Secondary

MeasureTime frame
To assess & compare post-operative morbidity between the two groups-including duration of hospital stay, ICU stay, mechanical ventilation, & incidence of renal impairment & arrhythmias & need for addition of secondary inotropes. Patient will be followed till 48 hours of post-operative period.Timepoint: One year hospital based study;To evaluate & compare early post-operative mortality between the two groups. Patient will be followed till 48 hours of post-operative period. Timepoint: One year hospital based study—

Countries

India

Contacts

Public ContactANINDYA A

Jawaharlal Nehru Medical College

manviveeresh@gmail.com9164000009

Outcome results

None listed

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