ACTRN12619000829112
Completed
Phase 2
Resuscitation in Paediatric Sepsis Using Metabolic Support– A Randomized Controlled Trial to Assess Impact on Survival Free of Organ Dysfunction
niversity of Queensland0 sites60 target enrollmentJune 7, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- niversity of Queensland
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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