NCT06478797

Early Resuscitation in Paediatric Sepsis Using Inotropes

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NATALIA LOPERA MUNERA · Academic / Other
• Sex: All
• Age: 28 Days – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Sepsis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

4 sites across 3 countries: Argentina, Bolivia, Paraguay