Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Composite adverse events of early versus conventional cessation of hydrocortisone
研究概览
简要总结
Septic shock is one of the causes of death in ICU and hospital. Refractory shock is the problem which healthcare providers should recognize though it is difficult to handle with. The corticosteroid called hydrocortisone is one of the treatment in refractory septic shock which requires vasopressor to maintain blood pressure. In recovery phase of septic shock and weaning off vasopressor, there is no definite way to taper off hydrocortisone.
详细描述
According to secondary outcomes of several studies analyzed in systemic review was shown adverse events from corticosteroid uses including hyperglycemia, hypernatremia, muscle weakness, and superimposed infection. This trials will compare composite adverse events in early versus conventional cessation of hydrocortisone in septic shock.
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
- •Patient >= 18 years old
- •Diagnosis Septic shock from the definition of SEPSIS III criteria in intensive care unit or medicine ward or surgical ward at Siriraj hospital
- •Received at least 1 catecholamines and hydrocortisone at least 200 mg/d
- •Maintain mean arterial pressure >= 65 mmHg even if titrate down catecholamines until low dose (<=0.1 mcg/kg/min)
排除标准
- •Patient sign Do not resuscitation and terminally ill
- •Pregnancy
- •Need long term steroid use due to other medical condition
研究组 & 干预措施
early cessation group
The pharmacist uses 100 ml of normal saline solution, packed out in the same format, dose, and administration of the drug were exactly the same as in the conventional cessation group. The experimental starts after required dose of vasopressor less than 0.1 mcg/kg/min. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.
干预措施: normal saline solution (Drug)
conventional cessation group
The pharmacist prepared hydrocortisone and normal saline solution 100 ml starts dose at least 200 mg/day according to doctor's order after patient meets the criteria of refractory septic shock then continues conventional cessation of hydrocortisone according to doctor's order after required dose of vasopressor less than 0.1 mcg/kg/min. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.
干预措施: Hydrocortisone and normal saline solution (Drug)
结局指标
主要结局
Composite adverse events of early versus conventional cessation of hydrocortisone
时间窗: within 14 days after randomization or until discharge from hospital, whichever came first
including level of capillary blood glucose \>= 180mg/dL(Hyperglycemia) , Plasma level of sodium\>= 150mmol/L(Hypernatremia), new onset of infection , and neuromuscular weakness(muscular impairment rating scale\>1
次要结局
- Number of participants with New onset of infection within 28 days(28 days)
- Number of participants with Alive days in 28 days with free renal replacement therapy(28 days after randomization or until discharge from hospital, whichever came first)
- Number of participants with Alive days in 28 days with free organ supports(28 days after randomization or until discharge from hospital, whichever came first)
- Number of participants with capillary blood glucose ≥ 150 mg/dL(within 14 days after randomization or until discharge from hospital, whichever came first)
- Duration of ICU length of stay(14 days after first dose hydrocortisone or until discharge from hospital, whichever came first)
- Level of minimum and maximum mean arterial pressure(within 14 days after randomization or until discharge from hospital, whichever came first)
- Number of participants with hypoglycemia(within 14 days after randomization or until discharge from hospital, whichever came first)
- Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge(within 14 days after randomization or until discharge from hospital, whichever came first)
- Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone(7 days after randomization or until discharge from hospital, whichever came first)
- Number of participants with 28-day mortality from any cause or until discharge from hospital(28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first)
- Concentration of insulin needed due to hyperglycemia(within 14 days after randomization or until discharge from hospital, whichever came first)
- Time to need of fluid bolus(within 14 days after randomization or until discharge from hospital, whichever came first)
- Time to reversal of shock(within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first)
- Duration of Ventilator free day(14 days after first dose hydrocortisone or until discharge from hospital, whichever came first)
- Number of participants with Alive days in 28 days with free mechanical ventilator(28 days after randomization or until discharge from hospital, whichever came first)