Assessing the Efficacy of Treatment with Vitamin C and Hydrocortisone in Children Admitted to Intensive Care Unit with Septic Shock.

Phase 2

Recruiting

• Conditions: Sepsis; Septic Shock; Infection - Other infectious diseases

• Registration Number: ACTRN12621000247875
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-08
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified