Phase 3 Study of Corticotherapy (Hydrocortisone Alone Versus Hydrocortisone Plus Fludrocortisone) Versus Corticotherapy Plus Intensive Insulin Therapy for Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 508
- 试验地点
- 8
- 主要终点
- In-hospital mortality
研究概览
简要总结
This study will compare, in adults with septic shock, the safety and efficacy of a combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids. In addition, this study will compare the efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone
详细描述
Objectives:
Comparison, in patients with septic shock, of efficacy and safety of the combination of moderate doses of corticosteroids and intensive insulin therapy to that of moderate doses of corticosteroids; and of efficacy and safety of hydrocortisone alone versus hydrocortisone plus fludrocortisone Methods
Study design :
This is a multicenter, prospective, randomised trial on parallel groups
Study treatments :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Patients admitted in intensive care units for septic shock and meeting all following criteria
- •Proven infection
- •Need for vasopressor to maintain systemic arterial tension above 90 mmHg
- •Multiple organ dysfunction as defined by a SOFA score ³
- •Need for treatment with moderate dose of corticosteroids
排除标准
- •One of the following :
- •Pregnancy
- •Less than 18 years old
- •Moribund (i.e. expected to die on day of intensive care unit admission)
研究组 & 干预措施
4
hydrocortisone, fludrocortisone and intensive insulin therapy
干预措施: fludrocortisone (Drug)
1
Hydrocortisone and convention glycemic control
干预措施: Hydrocortisone (Drug)
2
Hydrocortisone and fludrocortisone and conventional glucose control
干预措施: Hydrocortisone (Drug)
2
Hydrocortisone and fludrocortisone and conventional glucose control
干预措施: fludrocortisone (Drug)
3
Hydrocortisone and intensive insulin therapy
干预措施: recombinant human insulin (Drug)
3
Hydrocortisone and intensive insulin therapy
干预措施: Hydrocortisone (Drug)
4
hydrocortisone, fludrocortisone and intensive insulin therapy
干预措施: recombinant human insulin (Drug)
4
hydrocortisone, fludrocortisone and intensive insulin therapy
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
In-hospital mortality
时间窗: Day 180
次要结局
- Secondary outcomes :(Day 180)
- 90-day and 180-day mortality.(Day 180)
- Duration of life-supporting treatments (i.e. vasopressors and mechanical ventilation)(Day 180)
- Time to resolve multiple organ dysfunction, i.e. to obtain a SOFA score < 8(Day 180)
- Hospital length of stay.(Day 180)
- Number of hypoglycaemic events (blood glucose < 4 mmol/l) during insulin infusion(Day 180)
- Muscle weakness at discharge from intensive care unit, 90-day and 180-day(Day 180)
- Post traumatic stress disorders(Day 180)