Health Trials

Early Resuscitation in Paediatric Sepsis Using Inotropes

ConditionSepsis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age28-18
SponsorNATALIA LOPERA MUNERA

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

28 days and <18 years

Treated for sepsis

Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock

Parental/caregiver consent prior to or after enrolment

Disqualifiers

Preterm babies born <34 weeks gestation that have a corrected age of <28 days

Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment

Inotrope infusion commenced pre-enrolment

Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluid

    Other intervention

    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.

  • Adrenalin

    Drug

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival free of organ support at 28 days

Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy

Time frame
From time of randomization until 28 days, if death occurs, time is set to 0 days

Secondary outcomes

1

Recuitment rates

Secondary feasibility outcome 1

Time frame
12 months
2

Proportion of eligible randomised

Other feasibility 2

Time frame
12 months
3

Proportion of eligible consented using perspective consent and consent to continue

Other feasibility 3

Time frame
12 months
4

Time to initiation of inotropes between the control and the early inotrope arm

Other feasibility 4

Time frame
24 hours

Other outcomes

Sponsors and contacts

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NATALIA LOPERA MUNERA

Lead sponsor

Hospital General Pediátrico Niños de Acosta Ñu

Sponsor institution

University Children's Hospital, Zurich

Collaborator

Universidad Nacional del Nordeste, Argentina

Collaborator

Instituto Latino Americano de Sepse

Collaborator

Hospital Pablo Tobón Uribe

Collaborator

Source ClinicalTrials.gov

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