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Comparison of inotropes in children with cold septic shock

Norepinephrine plus Dobutamine versus Epinephrine as First line Vasoactive agents for Fluid Refractory Pediatric Septic Shock ââ?¬â?? A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015844
Enrollment
80
Registered
2018-09-26
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: null- Critically ill children in septic shock Health Condition 2: I958- Other hypotension

Interventions

Intervention1: Norepinephrine plus Dobutamine: Norepinephrine will be started at 0.1 mcg/kg/min and Dobutamine will be started at 10 mcg/kg/min through intravenous route. The dose will be increased de

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with fluid refractory cold septic shock

Exclusion criteria

Exclusion criteria: 1.Fulminant myocarditis 2.Congenital heart disease 3.Severe Acute Malnutrition 4.Chronic kidney disease 5.Children already on inotropes at the time of enrolment 6.Parents not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
Proportion of patients attaining shock resolution at 1 hour of enrolmentTimepoint: At 1 hour of enrolment

Secondary

MeasureTime frame
MortalityTimepoint: At day 28;No of children having rhythm disturbancesTimepoint: During vasoactive therapy;Proportion of patients attaining shock resolutionTimepoint: At 6 hours, 24 hours and 48 hours of enrolment;Proportion requiring other vasoactive agentsTimepoint: During PICU stay;pSOFA and PELOD-2 scoresTimepoint: At 24, 48 and 72 hours;Time to attain shock resolutionTimepoint: Time required for achieving therapeutic end points;Time to vasoactive agent withdrawalTimepoint: Time till stopping of vasoactive agents;Vasoactive inotrope scoreTimepoint: At 24 hours of enrolment

Countries

India

Contacts

Public ContactDr Jhuma sankar

AIIMS, New Delhi

jhumaji@gmail.com9818399864

Outcome results

None listed

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