Hyperglycemia and Effects of Daily 100 Milligrams Versus 200 Milligrams of Hydrocortisone Therapy in Patients With Septic Shock: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hyperglycemia
研究概览
简要总结
The purpose of this study is to compare hyperglycemia and other effects, include 28-day mortality and time to reversal of shock between 100 milligrams and 200 milligrams of hydrocortisone as initial dosage in patients with septic shock.
详细描述
The intervention group will be received 100 milligrams per day of hydrocortisone on the first three day the taper off, whereas the control group will be received 200 milligrams per day of hydrocortisone on the first three day the taper off. Hyperglycemia rate will be monitored every 6 hours after hydrocortisone is started until 24 hours after it is stopped.
Also, 28-day mortality will be follow after hydrocortisone is started.
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
- Double (Participant, Care Provider)
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
- •Septic shock
- •Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability
排除标准
- •Receive systemic steroid in past 3 months
- •Established adrenal insufficiency
- •Currently used in chemotherapy or immunosuppressive agents
- •Radiotherapy currently received
- •Known HIV infection
- •Pregnancy
研究组 & 干预措施
100 milligrams of hydrocortisone
100 milligrams per day of hydrocortisone is the starting dosage.
干预措施: Hydrocortisone (Drug)
200 milligrams of hydrocortisone
200 milligrams per day of hydrocortisone is the starting dosage.
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Hyperglycemia
时间窗: two years
Proportion of hyperglycemic patients
次要结局
- 28-day mortality(two years)
- Time to shock reversal(two years)
研究者
Kanchana Ngaosuwan
Doctor
Srinakharinwirot University