Placebo-controlled, Randomised, Double-blind Study to Investigate the Efficacy and Safety of Low Dose Hydrocortisone to Prevent the Development of Septic Shock in Patients With Severe Sepsis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 30
- 主要终点
- Septic shock
研究概览
简要总结
Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe sepsis according to ACCP/CCM criteria
- •Onset of severe sepsis < 48 hours
- •Informed consent
- •Effective contraception in fertile women
排除标准
- •Septic shock
- •Known hypersensitivity to hydrocortisone and additives
- •Glucocorticoid history which warrants continuation of glucocorticoid administration
- •Other indication for systemic glucocorticoid therapy
- •DNR-order
- •Moribund patient
- •Pregnancy
- •Breast feeding women
- •Age < 18 years
- •Other interventional study
- •Relationship to investigator
研究组 & 干预措施
Hydrocortisone
干预措施: Hydrocortisone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Septic shock
时间窗: 14 days
次要结局
- Immune response to hydrocortisone(6 days)
- Adrenal function(baseline)
- Mortality(28, 90, and 180 days; ICU and hospital)
- Length of stay(ICU and hospital (3-6 months))
- Time to death(28, 90, and 180 days)
- Time to septic shock(14 days)
- Mechanical ventilation(until ICU discharge)
- Renal replacement therapy(until ICU discharge)
- Other adverse events(28 days)
- Posttraumatic stress disorder / health-related quality of life(Hosptal discharge and 180 days after hospital discharge)
- Organ dysfunction (SOFA score)(until ICU discharge but day 14 at maximum)
- Frequency of weaning failure(until ICU discharge)
- Frequency and severity of muscle weakness(until ICU discharge)
- Frequency of gastrointestinal bleeding(28 days)
- Frequency of secondary infections(28 days)
- Delir(ICU discharge)
- Hypernatremia(14 days)
- Hyperglycemia(14 days)
研究者
Didier Keh
MD
Charite University, Berlin, Germany