Reposição de Esteróides em Crianças Com Choque Séptico
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- number of days free of vasoactive support after 7 days of septic shock diagnosis
研究概览
简要总结
Septic shock is a frequent reason for admission on pediatric intensive care units. Interventions which can change morbidity and mortality of septic shock patients are of great interest. Steroid replacement in adults with severe sepsis and septic shock have been extensively studied. It was recently demonstrated that low dose steroid (< 300mg/ day) used for more than 5 days was associated with decreased mortality and lower requirement of vasoactive support in the adult population that had a low response to the ACTH test. However, this was not confirmed in the latest results from the CORTICUS study. Use of low dose hydrocortisone, or any other steroid has not been studied in critically ill children. Mortality associated with sepsis in children has decreased in the last decade and currently it is close to 10%, making it difficult to power a study able to show reduced mortality. Taking into account the results from previous studies reporting the high incidence of adrenal failure and its association to worse outcome, we have designed a clinical trial to evaluate the effect of low dose hydrocortisone in children with septic shock: Cortisol Replacement in Children with Sepsis Study.
详细描述
Hypothesis Pediatric patients with septic shock have a high incidence of failure to respond to the ACTH test and would benefit of steroid replacement.
Design Randomized double-blind placebo controlled clinical trail. Outcome Primary: number of days free of vasoactive support after 7 days of septic shock diagnosis.
Methods
Study population:
All children admitted to PICU will be possible enrolled. Inclusion criteria will be (I) age between 1 month and 16 years; (II) septic shock according to the definitions of pediatric septic shock 2005; (III) inotrope requirement, as in dopamine > 5 mcg/kg/mim, dobutamine > 5 mcg/kg/min or any dose of noradrenaline or adrenaline after adequate fluid resuscitation. Exclusion criteria will be patients with (I) baseline disease associated to HPA axis dysfunction; (II) steroid use in the past 4 weeks; (III) previous use of etomidate; (IV) formal indication for steroids use, and (V) formal contraindication to steroid use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(I) age between 1 month and 20 years;
- •(II) septic shock according to the definitions of paediatric septic shock 2005; -(III) inotrope requirement, as in dopamine > 5 mcg/kg/mim, dobutamine > 5 mcg/kg/min or any dose of noradrenaline or adrenaline after adequate fluid resuscitation. -
排除标准
- •Exclusion criteria will be patients with
- •(I) baseline disease associated to HPA axis dysfunction;
- •(II) steroid use in the past 4 weeks;
- •(III) previous use of etomidate; (IV) formal indication for steroids use, and
- •(V) formal contraindication to steroid use.
研究组 & 干预措施
1
Hydrocortisone 6 mg/kg/day, 8 hourly, during 7 days or during the vasoactive drug infusion
干预措施: Hydrocortisone (Drug)
2
placebo
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
number of days free of vasoactive support after 7 days of septic shock diagnosis
次要结局
未报告次要终点