Skip to content

A study in children with tetralogy of fallot: Comparing two milrinone treatments to improve heart stability after surgery.

Comparison of Two regimens of milrinone infusion in paediatric patients undergoing Tetralogy of fallot repair - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103963
Enrollment
154
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: WITHOUT LOADING DOSE: Milrinone was Started as infusion 0.5 ug/kg/min without loading dose after patient went on cardio pulmonary bypass and continue as infusion 0.5-0.75 ug/kg/min in p

Sponsors

UNMICRC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patients (age: 6 months to 5 years) undergoing TOF repair.

Exclusion criteria

Exclusion criteria: Patients with significant renal or hepatic dysfunction, Patients with preoperative low cardiac output syndrom ,Patients who require extracorporeal membrane oxygenation (ECMO) support

Design outcomes

Primary

MeasureTime frame
Hemodynamic parameters (Heart rate, Systolic /Diastolic and Mean arterial blood pressure, Central venous pressure, Saturation,Urine Output , serum lactate level) Inotropic support requirements ( max vasoactive-inotropic score) Postoperative complications (low output syndrome, arrhythmias)Timepoint: Baseline before starting study 15 min after weaning from CPB At the end of surgery 6 hr after ICU admission 12 hr after ICU admission 24 hr after ICU admission

Secondary

MeasureTime frame
Length of stay in ICU Evaluate the safety profile of both milrinone infusion regimens including adverse effects such as hypotension, & thrombocytopenia Volume Administration: Compare the volume administration between two group Timepoint: Baseline before starting study 15 min after weaning from CPB At the end of surgery 6 hr after ICU admission 12 hr after ICU admission 24 hr after ICU admission

Countries

India

Contacts

Public ContactDrMilan Patel

U. N. Mehta Institute of Cardiology and Research Center

dr.divyakantparmar@gmail.com9825851055

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026