From Bolus to Infusion: Stress-Dose Steroid Methods and Prognostic Value in Septic Shock Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 28-Day All-Cause Mortality
研究概览
简要总结
Septic shock is a life-threatening condition in which infection causes dangerously low blood pressure and organ dysfunction despite fluid resuscitation and vasopressor treatment. Hydrocortisone is commonly used in patients with septic shock who continue to require vasopressors. However, it is uncertain whether hydrocortisone should be administered as a continuous intravenous infusion or as intermittent intravenous bolus doses.
This randomized controlled trial evaluates whether continuous intravenous hydrocortisone infusion improves clinical outcomes compared with intermittent intravenous hydrocortisone boluses in adult patients with septic shock. Participants receive either hydrocortisone 200 mg/day by continuous infusion or hydrocortisone 50 mg intravenously every 6 hours, in addition to standard septic shock management. The study evaluates 28-day mortality, recovery from shock, duration of vasopressor therapy, mechanical ventilation duration, intensive care unit stay, hospital stay, inflammatory markers, and organ dysfunction scores.
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)
盲法说明
Outcome assessors were unaware of participants' treatment assignments. Treatment allocation was maintained by an independent coordinator who was not involved in clinical management or outcome assessment.
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
- •Adults aged 18 years or older of either sex.
- •Diagnosis of septic shock according to Sepsis-3 criteria, defined as sepsis with persistent hypotension requiring vasopressor therapy to maintain a mean arterial pressure of at least 65 mmHg and a serum lactate level greater than 2 mmol/L despite adequate fluid resuscitation.
- •Admission to the intensive care unit at Benha University Hospitals.
排除标准
- •Known allergy or contraindication to hydrocortisone.
- •Known adrenal insufficiency.
- •Chronic systemic corticosteroid therapy for more than 1 month before enrollment.
- •Pregnancy or lactation.
- •Active gastrointestinal bleeding.
- •Immunosuppression.
- •Expected survival of less than 24 hours or imminent death from a non-infectious cause.
- •Psychiatric disorder that could interfere with study participation.
- •Coagulation disorder.
结局指标
主要结局
28-Day All-Cause Mortality
时间窗: At 28 days after ICU admission
Proportion of participants who died from any cause by day 28 after enrollment.
次要结局
- Sequential Organ Failure Assessment Score(Baseline and on days 3 and 5 after enrollment.)
- 7-Day Shock Reversal Rate(At day 7 after enrollment.)
- Duration of Septic Shock(Up to day 28 after enrollment.)
- Duration of Vasopressor Therapy(Up to day 28 after enrollment.)
- Duration of Mechanical Ventilation(Up to day 28 after enrollment.)
- Intensive Care Unit Length of Stay(Up to day 28 after enrollment.)
- Hospital Length of Stay(Up to day 28 after enrollment.)
研究者
Ahmed Eldesouki
Lecturer of Critical Care Medicine
Benha University