Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reversal of shock: Off Vasopressors24h
研究概览
简要总结
Parenterally administered ascorbic acid modulates sepsis-induced inflammation & coagulation. Intravenous ascorbic acid infusion was well tolerated in a study & may positively impact multiple organ failure & biomarkers of inflammation & endothelial injury. Thiamine has a role as a metabolic resuscitator in septic shock. A relative adrenal insufficiency is postulated in patients with septic shock. There is thus encouraging emerging data on the use of thiamine, steroids & vitamin C in septic shock. We plan a randomised placebo controlled clinical trial to study the effect of these drugs in septic shock on 28 mortality, inotrope withdrawal and ICU stay
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted to the Critical Care Unit who demonstrate 2 or more of the following symptoms : Temperature <36 or >38 Pulse >90 bpm White Cell Count of <4000 or >11000 Respiratory Rate >20 New Confusion Systolic BP < 90 mm of Hg or diastolic<60 or MAP<65 for >1h despite fluid resuscitation Culture positive or strong suspicion of infection with Procalcitonin level >2ng/ml.
排除标准
- •Pregnant patients 2)Patients who die within 24 hrs of admission 3)Terminal illness.
结局指标
主要结局
Reversal of shock: Off Vasopressors24h
时间窗: Reversal of shock: Off Vasopressors24h | 28-Day Mortality Rate
28-Day Mortality Rate
时间窗: Reversal of shock: Off Vasopressors24h | 28-Day Mortality Rate
次要结局
- Procalcitonin clearance(length of icu stay)