Initiation of Hydrocortisone and Fludrocortisone in Adult Patients With Septic Shock：A Prospective Randomized Controlled Clinical Trial
概览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Northern Jiangsu People's Hospital
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- 90-day mortality
概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the combination therapy of hydrocortisone and fludrocortisone among adult patients with septic shock.
详细描述
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, and septic shock represents its most severe form, characterized by profound circulatory and metabolic abnormalities with high mortality.
Current international guidelines recommend intravenous hydrocortisone as adjunctive therapy in patients with septic shock who remain hypotensive despite adequate fluid resuscitation and vasopressor treatment. However, critically ill patients may exhibit relative deficiencies of both glucocorticoid and mineralocorticoid activity, and hydrocortisone alone may not fully meet the physiological demands under severe stress. In recent years, combination therapy with hydrocortisone and fludrocortisone has been investigated, but published trials have reported inconsistent results regarding mortality, shock reversal, and adverse events.
Therefore, this randomized controlled trial aims to evaluate the efficacy and safety of hydrocortisone combined with fludrocortisone, compared with standard therapy, in patients with 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)18≤Age≤90; (2)Diagnosis of septic shock within 12 h.
排除标准
- •Patients meeting any of the following conditions will be excluded:
- •Systemic corticosteroid therapy within the last 3 months before septic shock;
- •High-dose steroid therapy;
- •Immunosuppression;
- •Known allergy to hydrocortisone or fludrocortisone;
- •Presence of gastrointestinal bleeding, perforation, or other conditions requiring fasting;
- •Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
- •Refusal of the attending staff or patient family;
- •Current participation in another clinical trial.
研究组 & 干预措施
Hydrocortisone plus Fludrocortisone
Hydrocortisone: 200 mg per day administered by continuous intravenous infusion for up to 7 days or until ICU discharge, whichever occurs first.
Fludrocortisone: 50 μg administered orally or via nasogastric tube once daily for up to 7 days or until ICU discharge, whichever occurs first.
干预措施: Hydrocortisone plus Fludrocortisone (Drug)
Standard care
Patients will receive standard care for septic shock according to current international guidelines, including fluid resuscitation, vasopressor therapy, antimicrobial treatment, and other supportive measures, including the use of hydrocortisone at the discretion of the treating physician, but without fludrocortisone.
干预措施: Standard care (Other)
结局指标
主要结局
90-day mortality
时间窗: 90 days after randomization
All-cause mortality at day 90 after randomization
次要结局
- 28-day mortality(28 days after randomization)
- ICU mortality(From randomization to ICU discharge (up to 90 days))
- Hospital mortality(From randomization to hospital discharge (up to 90 days))
研究者
Qing-quan Lv
Principal Investigator
Northern Jiangsu People's Hospital