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

Phase 2

Completed

• Conditions: Sepsis; Septic Shock; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12619000829112
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Study Completion: 2021-06-07
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Children age =>28 days and <18 years which are admitted to the Paediatric Intensive Care Unit with a diagnosis of suspected septic shock requiring vasopressors/inotropes for >2hours (i.e. fluid-refractory shock).

Exclusion Criteria

- Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- Known chronic renal failure not related to sepsis
- Known chronic hepatic failure not related to sepsis
- Known diseases affecting the steroid axis, including pituitary disease, congenital adrenal hypoplasia, Cushing or Addison’s disease
- Palliative care patient/patient with limitation of treatment (not for inotropes, CPR, ECLS, intubation and ventilation)
- Cardiopulmonary arrest in the past two hours requiring CPR >2 min, or death is deemed to be imminent or inevitable
- Major bleeding with haemorrhagic shock
- Sepsis is not likely to be the cause of shock
- Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- Patients with sepsis/septic shock transferred form another ICU or hospital who have been treated with inotropes for septic shock for >24 hours
- Patients with known history of oxalate nephropathy
- Patients with acute beri-beri disease
- Patients with acute Wernike’s encephalopathy
- Patients with known malaria
- Patients with known of suspected scurvy
- Patient is receiving treatment for systemic fungal infection or has documented strongyloides infection at the time of randomization
- Patient undergoing active chemotherapy for cancer treatment (incl. all administration routes)
- Enrolment in RESPOND study <6 months ago (except for RESPOND ED randomization prior to RESPOND PICU within the same sepsis episode)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main feasibility outcome is compliance with study protocol during the pilot.<br><br>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.<br><br>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]