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Comparison of two commonly used vasoactive agents in children with septic shock

Norepinephrine versus Epinephrine as the initial vasoactive agent in pediatric septic shock-A multicenter RCT

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019078
Enrollment
120
Registered
2019-05-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Norepinephrine: Norepinephrine infusion will be started at 0.05 microgram/kg/minute in children requiring vasoactive agents and increased at 15 minute intervals till target BP is achiev

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2 months to 17 years with early septic shock, defined as children with suspect or confirmed sepsis and unresolved shock/hypoperfusion after the initial 20ml/kg fluid bolus.

Exclusion criteria

Exclusion criteria: 1. Children with fulminant myocarditis 2. Children with unrepaired congenital heart disease 3. Post-operative sepsis/septic shock within 72 hours of bypass surgery. 4. Children with Severe Acute Malnutrition 5. Children with chronic kidney disease. 6. Parents not willing to participate in the study 7. Caregiver/Physician unwilling for patient to be enrolled 8. Post-arrest shock and cardiac dysfunction 9. Moribund patients in whom anticipated survival

Design outcomes

Primary

MeasureTime frame
Fluid volume in ml/kg required in first 6 hours of beginning vasoactive agentsTimepoint: At 6 hours of enrollment

Secondary

MeasureTime frame
MoratlityTimepoint: Measured till 28 days from the time of admission. Measured at 28 days or earlier if death occurs.;Organ dysfunction scoresTimepoint: At 24, 48 and 72 hours;Proportion of children achieving shock resolutionTimepoint: Measured at 6,12, 24, 48 and 72 hours of resuscitation

Countries

India

Contacts

Public ContactJhuma Sankar

All India Institute of Medical Sciences

jhumaji@gmail.com

Outcome results

None listed

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