| CTRI Number |
CTRI/2026/02/103963 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in children with tetralogy of fallot: Comparing two milrinone treatments to improve heart stability after surgery. |
|
Scientific Title of Study
|
Comparison of Two regimens of milrinone infusion in paediatric patients undergoing Tetralogy of fallot repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMilan Patel |
| Designation |
P.G Student |
| Affiliation |
U N Mehta Institute of Cardiology and Research Center |
| Address |
Room NO 424 Block A Department of Cardiac Anaesthesia NEW HOSTEL BULDING U N Mehta Institute of Cardiology and Research Center Civil Hospital Campus Asarwa Ahmedabad-380016 Gujarat India
Ahmadabad
GUJARAT
380016
India |
| Phone |
8128601816 |
| Fax |
|
| Email |
milan88863@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDivyakant Parmar |
| Designation |
Associate Professor |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Center |
| Address |
A Block Department of Cardiac Anesthesia U N Mehta Institute of Cardiology and Research Center Civil Hospital Campus Asarwa Ahmedabad-380016 Gujarat India
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825851055 |
| Fax |
|
| Email |
dr.divyakantparmar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMilan Patel |
| Designation |
PG Student |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Center |
| Address |
Room no 424 Department of Cardiac Anesthesia U N Mehta Institute of Cardiology and Research Center Civil Hospital Campus Asarwa Ahmedabad-380016 Gujarat India
Ahmadabad
GUJARAT
380016
India |
| Phone |
8128601816 |
| Fax |
|
| Email |
milan88863@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UNMICRC |
| Address |
U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDivyakant Parmar |
U. N. Mehta Institute of Cardiology and Research Center |
A block, 7th floor, Pediatric cardiac OT and Post Operative ICU, Department of Cardiac Anesthesia
Ahmadabad
GUJARAT |
9825851055
dr.divyakantparmar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee UNMICRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
WITH LOADING DOSE |
Milrinone was started as a loading dose 50mcg/kg over 10 min after aortic declamping and continued as infusion (0.5-0.75 mcg/kg/min) postoperatively in the pediatric cardiac surgical care unit (PSICU) |
| Intervention |
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 paediatric cardiac intensive care unit |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients (age: 6 months to 5 years) undergoing TOF repair. |
|
| ExclusionCriteria |
| Details |
Patients with significant renal or hepatic dysfunction, Patients with preoperative low cardiac output syndrom ,Patients who require extracorporeal membrane oxygenation (ECMO) support |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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) |
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 Outcome
|
| Outcome |
TimePoints |
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
|
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
|
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tetralogy of Fallot (TOF) is a complex congenital heart defect characterized by four key components: ventricular septal defect, pulmonary stenosis, right ventricular hypertrophy, and an overriding aorta. Postoperative management of these patients is critical and often requires careful titration of inotropic and vasodilatory support to optimize cardiac function and minimize morbidity.
Milrinone, a phosphodiesterase III inhibitor, is commonly used in the perioperative period for patients undergoing cardiac surgery. It provides inotropic support and vasodilation, which can improve cardiac output and reduce pulmonary vascular resistance. However, the optimal dosing strategy for milrinone in pediatric patients undergoing TOF repair remains a topic of debate.
This study aims to compare two different milrinone infusion . By evaluating the hemodynamic effects, vasopressor and inotrope requirements, and postoperative outcomes, this study seeks to provide insights into the most effective and safe milrinone dosing strategy for this patient population.
The findings of this study will contribute to the development of evidence-based guidelines for the patient outcomes and reducing mortality |