Hydrocortisone and Fludrocortisone Versus Hydrocortisone Alone in Critically Ill Medical Patients With Septic Shock
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Time to Resolution of Shock
研究概览
简要总结
This study will be conducted as a single-center, prospective, open-label, randomized trial that will evaluate adult patients admitted with septic shock to the medical critical care unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus fludrocortisone is associated with a faster resolution of shock (defined as 24 hours vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill septic shock patients.
详细描述
For three consecutive months, side 1 of the medical critical care unit (MCC1) will receive hydrocortisone alone and side 2 (MCC2) will receive the combination of hydrocortisone and fludrocortisone. After the initial three months, this will be flipped and patients admitted to MCC1 will receive the combination while patients in MCC2 will receive hydrocortisone alone for three consecutive months. This change in group assignments will occur to account for the difference in number of beds between MCC1 and MCC2, and to minimize the potential differences in patient acuity by location.
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
- None
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
- •Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
- •Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group
排除标准
- •Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
- •Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
- •Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
- •Patients not appropriate for study inclusion as determined by provider discretion
- •Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
- •Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
- •Any patient receiving greater than one dose of hydrocortisone 100 mg
- •Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone
研究组 & 干预措施
Combination
Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h
干预措施: Hydrocortisone (Drug)
Hydrocortisone only
Hydrocortisone 50 mg IV Q6h
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Time to Resolution of Shock
时间窗: Up to one week
Hours for patient to achieve 24 hours vasopressor free
次要结局
未报告次要终点