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Early Resuscitation in Paediatric Sepsis Using Inotropes

NCT06478797 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    collaborator OTHER

  • Universidad Nacional del Nordeste, Argentina

    collaborator OTHER

  • Instituto Latino Americano de Sepse

    collaborator UNKNOWN

  • Hospital Pablo Tobón Uribe

    collaborator OTHER

  • NATALIA LOPERA MUNERA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • Argentina
  • Bolivia
  • Paraguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478797 on ClinicalTrials.gov