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A study on comparison between the effectiveness of Dobutamine with Glyceryl Trinitrate versus Milrinone in the Treatment of Acute Heart Failure in children, conducted in a government medical college of eastern India

Dobutamine with glyceryl nitrate versus milrinone in treatment of acute heart failure with reduced ejection fraction in pediatrics: a randomized controlled trial in a tertiary care center of eastern India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101645
Enrollment
60
Registered
2026-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: I501- Left ventricular failure, unspecified

Interventions

Intervention1: dobutamine and glycerile trinitrate: dobutamine infusion at the rate of 10 microgram per kg per minute with glyceryl trinitrate infusion at the rate of 0.6 microgram per kg per minute I

Sponsors

IPGMER and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 month to 12 years with clinical features corroborating with Class III and IV of modified Ross classification AND With Echocardiography criteria of ejection fraction less than 40%

Exclusion criteria

Exclusion criteria: 1. Parents or patients not giving consent or assent respectively 2. Children who has left ventricular outflow tract obstruction 3. Children with hemodynamically significant congenital heart disease 4. Children with sepsis 5. Children having Arrhythmia 6. Children with heart failure secondary to Hypertension (BP greater than 95 percentile)

Design outcomes

Primary

MeasureTime frame
Resolution of acute heart failure with reduced ejection fraction which is defined by Class I of modified Ross classification. Outcomes are 1. Time to resolve heart failure 2. Maximum dose of drug required 3. Time required to reach the maximum dose Timepoint: baseline, then every 6 hours till heart failure resolves

Secondary

MeasureTime frame
Data about safety of the drugsTimepoint: after heart failure resolves, or if any adverse event occurs;Complications: i) Hypotension ii) Supportive measures e.g. fluid resuscitation, inotropes etc. iii) Whether Furosemide is to be continued during infusion therapy at least @ 2mg/kg/day iv) Other complications not listed above Timepoint: baseline, then every 6 hours till heart failure resolves

Countries

India

Contacts

Public ContactShatanik Sarkar

Institute of Post Graduate Medical Education and Research

baseline@gmail.com9433543732

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026