Steroids in Pediatric Acute Lung Injury/ARDS Trial: A Blinded, Placebo-controlled, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of mechanical ventilation
研究概览
简要总结
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are devastating disorders associated with lung inflammation, low oxygen levels and respiratory failure in children. Prevalence of ALI ranges from 2.2 to 12 per 100,000 children per year. Using these estimates, up to 9,000 children each year will develop ALI/ARDS, which may cause upto 2,000 deaths per year. Currently, there are no specific therapies directed against ARDS/ALI in children. In adult patients, use of steroids early in the course of ARDS appears promising. There are no published clinical trials examining the use of steroids for the treatment of ALI/ARDS in children.
Hypothesis:
Subjects with ALI/ARDS receiving steroids early in the course of disease (within 72 hours) and longer than 7 days will have improved clinical outcomes as compared to placebo control group as defined by (a) a decreased duration of mechanical ventilation and (b) significantly increased PaO2/FiO2 ratios.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 1 month and 18 years of age; AND
- •Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:
- •acute onset of the disease,
- •PaO2/FiO2 ratio <300,
- •evidence of bilateral infiltrates on chest radiography, and
- •no evidence of cardiac dysfunction; AND
- •Intubated and mechanically ventilated.
排除标准
- •Underlying disease requiring steroids >0.5mg/kg/day of methylprednisolone (eg. Asthma)
- •HIV positive, or have any other congenital or acquired immunodeficiency;
- •Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care
- •Cytotoxic therapy within the past 3 weeks
- •Major gastrointestinal bleeding within last 1 month
- •Extensive burns (>20% total body surface area of full- or partial-thickness burns)
- •Known or suspected adrenal insufficiency
- •Vasculitis or diffuse alveolar hemorrhage
- •Bone marrow or lung transplant
- •Disseminated fungal infections
- •Severe chronic liver disease
- •Other conditions with estimated 6-month mortality of 50% or higher
研究组 & 干预措施
Experimental Group
Intervention: Subjects in this study group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
干预措施: methylprednisolone (Drug)
Placebo Group
Intervention: The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline. The placebo group with receive the masked study drug in infusion rates that mimic the infusions received by the experimental group.
干预措施: Normal Saline (0.9%) (Drug)
结局指标
主要结局
Duration of mechanical ventilation
时间窗: 0-28 days
Number of hours required for positive pressure ventilation after the start of study drug
次要结局
- Incidence of nosocomial infections(0-35 days)
- Improvement in oxygenation(0-28 days)
- Incidence of hyperglycemia(0-28 days)