An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The primary outcome measure for this study is the number of hours receiving steroid dosing.
研究概览
简要总结
Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP > 65 mm Hg off of vasopressors).
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
- •Patients who are 18 years of age or older
- •Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient
- •Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock
排除标准
- •Patients with documented allergic or anaphylactic reactions to corticosteroids
- •Patients who have received steroid therapy within 6 months of presentation
- •Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone
- •Patients who have received etomidate in the preceding 12 hours
- •Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome).
- •Documented Human Immunodeficiency Virus (HIV) infection
- •Pregnancy
- •Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids
- •Administration of additional medications which may suppress the hypothalamic-pituitary axis:
- •Ketoconazole
- •Aminoglutethimide
- •Megestrol acetate
研究组 & 干预措施
Experimental group
Corticosteroids discontinued 24 hours after cessation of vasopressor therapy or 7 days, which ever comes first.
干预措施: Corticosteroid (Drug)
Standard of care group
Standard corticosteroid therapy given for 7 days as treatment for adrenal insufficiency during septic shock.
干预措施: Corticosteroid (Drug)
结局指标
主要结局
The primary outcome measure for this study is the number of hours receiving steroid dosing.
时间窗: 7 days
次要结局
- A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.(up to 28 days)