None listed
Conditions
Brief 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.
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 500-1000ml 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
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
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
28 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
Reword to: 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. - Major bleeding with haemorrhagic shock - Sepsis is not likely to be the cause of shock - Enrolment in RESPOND study <6 months ago (except for RESPOND ED randomization prior to RESPOND PICU within the same sepsis episode)
Outcome results
None listed