Effectiveness of hydrocortisone v/s combination of dexamethasone with fludrocortisone for shock reversal in adult patients with septic shock: a double blinded non inferiority randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time for shock reversal, defined as time from initiation of steroid therapy to discontinuation of noradrenaline for 24 hours to a target MAP of 65mmHg.
研究概览
简要总结
Septic shock patients coming to the ICU who require noradrenaline infusion to maintain mean arterial blood pressure more than or equal to 65mmHg for at least 4 hours will be divided into two parallel groups randomly. Hydrocortisone group will receive injection of Hydrocortisone 50mg IV QID for 7 days, till shock reversal or till death, whichever is earlier. The dexamethasone group will receive injection of dexamethasone 2mg IV QID and tablet fludrocortisone 100ug OD for 7 days, till shock reversal or till death, whichever is earlier. The primary outcome is to compare the time of shock reversal between the two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •patients presenting with septic shock to ICU requiring vasopressors to maintain mean arterial pressure more than or equal to 65mmHg for at least 4 hours.
排除标准
- •Patients already on steroids or likely to be on steroids for reasons other than septic shock.
- •Patient refusal known allergies to study drugs.
结局指标
主要结局
Time for shock reversal, defined as time from initiation of steroid therapy to discontinuation of noradrenaline for 24 hours to a target MAP of 65mmHg.
时间窗: at every 24 hours for 7 days.
次要结局
- To compare between the two groups(1) ICU mortality rate)
研究者
Jayanta Kumar Mitra
AIIMS Bhubaneswar