跳至主要内容
临床试验/ACTRN12621000247875
ACTRN12621000247875招募中2 期

Resuscitation in Paediatric Sepsis using Vitamin C and Hydrocortisone - A Randomized Controlled Multicentre Trial - assessing the effect on time alive and free of vasopressors

The University of Queensland0 个研究点目标入组 384 人开始时间: 2021年3月8日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
384

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
7 Days 至 17 Years(—)
性别
All

入选标准

  • 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.

排除标准

  • - 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

研究者

相似试验

Assessing the Efficacy of Treatment with Vitamin C... | 临床试验