ACTRN12619000828123
Recruiting
Phase 2
Resuscitation in Paediatric Sepsis Using Early Inotropes– – A Randomized Controlled Trial to Assess Impact on Survival Free of Organ Dysfunction
niversity of Queensland0 sites80 target enrollmentJune 7, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- niversity of Queensland
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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. To be eligible, the child must have received at least 20ml/kg of intravenous fluid bolus(es) in the past four hours with the clinician deciding to continue treating for signs of shock.
Exclusion Criteria
- •\- Preterm babies born \<34 weeks gestation that have a corrected age of \<28 days
- •\- Children who received \=\>40ml/kg of fluid during the 4 hours pre enrolment
- •\- Children on Inotrope infusion
- •\- Lack of access (intraosseus, central venous, peripheral) to administer fluids and/or inotropes after 60minutes of enrolment.
- •\- Known cardiomyopathy or chronic cardiac failure
- •\- Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment.
- •\- Known chronic renal failure
- •\- Known chronic hepatic failure
- •\- 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 during this admission.
Outcomes
Primary Outcomes
Not specified
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