ACTRN12621000247875
Recruiting
Phase 2
Resuscitation in Paediatric Sepsis using Vitamin C and Hydrocortisone - A Randomized Controlled Multicentre Trial - assessing the effect on time alive and free of vasopressors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- The University of Queensland
- Enrollment
- 384
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Criterion 1: Child aged \>\=7 days and \<18 years and admitted to PICU.
- •Criterion 2: Decision by treating physician to treat as sepsis (including parenteral antibiotics and inotropes)
- •Criterion 3: Treatment of septic shock with vasopressor/inotrope therapy for \>1 hour, or at a Vasopressor\-Inotrope\-Score of at least 10\.
- •Inotrope requirement will be calculated by means of the Vasoactive\-Inotrope Score (VIS)63: VIS \= dopamine dose (micgrogram/kg/min) \+ dobutamine dose (microgram/kg/min) \+ 100 x adrenaline dose (microgram/kg/min) \+ 100 x noradrenaline dose (microgram/kg/min) \+ 10 x milrinone dose (microgram/kg/min) \+ 10,000 x argipressin(vasopressin) dose (unit/kg/min). Note: vasopressin doses are often recorded as mU/kg/hour, which needs conversion to U/kg/min for the VIS score.
Exclusion Criteria
- •\- Preterm babies born \<34 weeks gestation that have a corrected age of \<7 days
- •\- Known chronic renal failure (defined as requiring continuous RRT prior to the onset of sepsis)
- •\- 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
- •\- Patients with sepsis/septic shock who have been treated with inotropes for septic shock for \>24 hours
- •\- Patients with known glucose\-6 phosphate dehydrogenase (G\-6PD) deficiency
- •\- Patients with known history of oxalate nephropathy
- •\- Patients with known malaria
- •\- Enrolment in RESPOND study within the past 6 months
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Vitamin C in Children with Septic Shock- A Randomised Controlled TrialCTRI/2020/01/022886All India Institute of Medical Sciences218
Completed
Phase 1
Vitamin C administration in severe sepsisACTRN12617001184369Dr Anitra Carr40
Completed
Phase 2
Resuscitation in Paediatric Sepsis Using Metabolic Support (RESPOND-PICU)SepsisSeptic ShockInfection - Studies of infection and infectious agentsACTRN12619000829112niversity of Queensland60
Not yet recruiting
Not Applicable
Role of Vitamin C in very sick childreHealth Condition 1: R652- Severe sepsisCTRI/2020/07/026703Meenakshi Rawat
Completed
Not Applicable
Fluid treatment for severe infections in childreseptic shockfluid resuscitationInfection - Other infectious diseasesCardiovascular - Other cardiovascular diseasesRespiratory - Other respiratory disorders / diseasesACTRN12614000824662The Royal Children's Hospital50