RecruitingPhase 2ACTRN12619000828123

Resuscitation in Paediatric Sepsis Using Early Inotropes (RESPOND-ED)

Resuscitation in Paediatric Sepsis Using Early Inotropes– – A Randomized Controlled Trial to Assess Impact on Survival Free of Organ Dysfunction

Sponsor

University of Queensland

Enrollment

80 participants

Start Date

Jul 21, 2019

Study Type

Interventional

Conditions

Sepsis Septic Shock

Summary

In view of the potential harm related to high volume fluid administration in septic shock, fluid-sparing algorithms using early intravenous inotropes to treat shock have been proposed as an alternative strategy. This multicentre pilot pragmatic open label randomized controlled Trial (RCT) compares early inotropes started after 20ml/kg fluid resuscitation with standard care defined as providing up to 40-60ml/kg fluid resuscitation prior to initiation of inotropes as per the American College of Critical Care Medicine recommendations. We hypothesize that in children presenting with sepsis and septic shock, a fluid-sparing algorithm using early inotropes delivered early during resuscitation is feasible and will lead to a more rapid resolution of shock and reduced duration of organ dysfunction.

Eligibility

Sex: Both males and femalesMin Age: 28 DayssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

Septic shock in children — when a severe infection causes the body's circulation to dangerously collapse — is a medical emergency. Current guidelines recommend giving large amounts of intravenous fluids to stabilise the child before starting medications to support blood pressure (called inotropes). However, there is growing concern that very large volumes of fluid may actually harm some children, contributing to complications like fluid build-up in the lungs. The RESPOND-ED study is testing whether starting inotropes earlier — after just 20 mL/kg of fluid rather than the standard 40–60 mL/kg — is feasible, safe, and leads to faster recovery from shock. Children aged 28 days to 17 years who are being treated for sepsis or septic shock in emergency departments across multiple hospitals will be randomly assigned to the early inotrope approach or standard care. Children with pre-existing heart conditions, chronic kidney or liver disease, or those who have already received large amounts of fluid before the study team can enrol them are not eligible. This research could lead to a kinder, more targeted approach to treating septic shock in children, potentially reducing the harm caused by fluid overload.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention: Early Inotropes: Early Inotropes: Goal-Directed Therapy with initiation of intravenous inotropes after the initial fluid bolus (20ml/kg, minimal amount 10-20ml/kg fluid bolus; (or 500

Intervention: Early Inotropes: Early Inotropes: Goal-Directed Therapy with initiation of intravenous inotropes after the initial fluid bolus (20ml/kg, minimal amount 10-20ml/kg fluid bolus; (or 500-1000ml fluid bolus in patients >50kg). The inotrope used is diluted adrenaline initiated at 0.05 to 0.1 (up to 0.3) mcg/kg/min. Dilution is used to fasten drug delivery and response to drug rate changes, to reduce risks with extravasation, and to facilitate peripheral application. Adrenaline will be prepared in 50ml syringes in 5% Dextrose solution that will be connected to peripheral, intraosseus, or central vascular access device. Drug delivery will occur through guardrails or similar system to ensure safe delivery of applied standardized drug concentrations. The study treatment will be given as continuous infusion for the duration of resuscitation until resolution of shock, discharge from intensive care unit, death, decision of the treating physician to stop or replace with other inotrope, or occurrence of major side effects, whichever occurs first. Compliance with protocol will be assessed through the prospective institutional drug charts, and the prospective study case report form