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Comparative Efficacy of Levosimendan and Milrinone in Catecholamine-Resistant Septic Shock with Myocardial Dysfunction in Children: A Single-Center, Open-Label RCT

Comparison Of Efficacy Of Levosimendan Versus Milrinone In Catecholamine Resistant Septic Shock With Myocardial Dysfunction In Children : A Single-Center, Open-Label Randomized controlled Trial - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083025
Enrollment
42
Registered
2025-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: levosimendan: Drug levosimendan @ 0.05mcg/kg/min. After 15 min if no response then increase Drug levosimendan @ 0.1mcg/kg/min After 15 min if no response then increase Drug levosimen

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES PATNA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the patients admitting in Paediatric emergency and pediatric intensive care unit, AIIMS Patna, with diagnosis of catecholamine resistant septic shock with and cardiac Index less than 3.3L/MIN/M2

Exclusion criteria

Exclusion criteria: Patient requiring CPR at presentation Cardiomyopathy, cardiothoracic surgery within the previous 14 days. congenital heart disease

Design outcomes

Primary

MeasureTime frame
improvement of cardiac function based on fractional shortening and cardiac index (by 2D ECHO), Heart rate & Blood pressure (age & sex adjusted), lactate levels. Timepoint: 1 DAY

Secondary

MeasureTime frame
Time taken for improvement in cardiac function, survival outcome. Timepoint: AT DISCHARGE

Countries

India

Contacts

Public ContactPawan Kumar

AIIMS, Patna

drarunp@aiimspatna.org7005783748

Outcome results

None listed

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