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NOT YET RECRUITING
NCT06478797
PHASE2

Early Resuscitation in Paediatric Sepsis Using Inotropes

Sponsor: NATALIA LOPERA MUNERA

View on ClinicalTrials.gov

Summary

Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)

Official title: Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)

Key Details

Gender

All

Age Range

28 Days - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-07

Completion Date

2025-12

Last Updated

2024-06-27

Healthy Volunteers

No

Conditions

Interventions

OTHER

Fluid

Sepsis will be treated with standardized therapy protocol, where participants receive fluids (balanced or non-balanced crystalloids, or colloids) to be resuscitated. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes.

DRUG

Adrenalin

Sepsis will be treated with early inotropes, where participants will receive adrenaline at a dose of 0.05 - 0.1 mcg/kg/min via peripheral intravenous, intraosseous, or central venous routes after the first fluid bolus of 20 ml/kg

Locations (4)

Hospital de Niños "Dr. Orlando Alassia"

Santa Fe, Argentina

Hospital Regional San Juan De Dios Tarija

Tarija, Bolivia

Hospital De Clínicas

Asunción, Paraguay

Hospital Niños de Acosta Ñu

San Lorenzo, Paraguay