Resuscitation in Paediatric Sepsis Using Metabolic Support (RESPOND-PICU)

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: 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 CONDITION: Emergency medicine ‐ Resuscitation Infection ‐ Studies of infection and infectious agents Sepsis;Septic Shock; ; Sepsis ; Septic Shock PRIMARY OUTCOME: The main feasibility outcome is compliance with study protocol during the pilot. ; ; We will assess the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form to assess compliance with the study protocol.[28 days after randomisation] The primary outcome is defined as survival free of organ dysfunction, censored at 28 days.; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form to assess organ dysfunction as defined by established organ dysfunction scoring using laboratory and clinical variables. Organ dysfunction will be defined as per the 2005 International Pediatric Sepsis Consensus Definition Conference criteria.[28 days after randomisation] SECONDARY OUTCOME: ; PICU free survival at 7 and 28 days. ; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation] ; Time to normalisation of lactate ; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation ] Survival free of vasopressor support at 7 and 28 days ; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation] 28‐day mortality ; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomization] Functional Status 6 months post enrolment ; ; Parents will be sent questionnaires by the study team. The questionnaires will be built using validated tools (Functional Status Score, Ages and Stages (<5 years), Strengths and Difficulties (>5 years)).[6 months post randomisation] Hospital length of stay ; ; ; Parents will be sent questionnaires by the study team. The questionnaires will be built using validated tools (Pediatric Quality of Life).[ ; 6 months from randomisation] Survival free of multiorgan dysfunction at 7 and 28 days ; ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomization] Time to reversal of shock ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation] Quality of life 6 months post enrolment ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation ] Time to reversal of tachycardia ; We will access the prospective hospital charts (including electronic health records and paper‐based charts) and the study case report form[28 days from randomisation ] INCLUSION CRITERIA: Children age >28days and <18 years where the decision is made by the treating physician to launch the institutional paediatric sepsis bundle treating for sepsis or septic shock. The child must have received at least 20ml/kg of intravenous fluid to be eligible.
Epistemonikos ID: 60939552279c2c26f4103232fb43b6869d6095e8
First added on: Aug 24, 2024