Early Resuscitation in Paediatric Sepsis Using Inotropes (ANDES-CHILD)

NATALIA LOPERA MUNERA

Status and phase: Not yet enrolling; Phase 2

Conditions: Sepsis

Treatments: Drug: Adrenalin; Other: Fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT06478797

IRB: 00006311

Details and patient eligibility

About

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)

Enrollment: 40 estimated patients

Sex: All

Ages: 28 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Cardiomyopathy or chronic cardiac failure
• Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment
• Known chronic renal failure (defined as requiring renal replacement therapy)
• Known chronic hepatic failure
• Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)
• Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, or death is deemed to be imminent or inevitable during this admission.
• Major bleeding with haemorrhagic shock
• Sepsis is not likely to be the cause of shock
• Previous enrollment in ANDES-CHILD

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control group

Active Comparator group

Description:

Sepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes

Treatment:

Other: Fluid

Intervention group

Experimental group

Description:

Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg

Treatment:

Drug: Adrenalin