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
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
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