Steroids, Thiamine and Ascorbic Acid Supplementation in Septic Shock (STASIS): A Prospective Crossover Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 主要终点
- In-hospital or 28-day mortality rate
研究概览
简要总结
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).
详细描述
This trial is designed as a multi-center prospective, double-blinded, randomized controlled study. The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes). The calculated sample size is 80. Subjects will be followed for 28 days or until hospital discharge.
Patients eligible for inclusion must be admitted with septic shock (as defined by SEPSIS-3) requiring vasopressors to maintain MAP ≥ 65 AND serum lactate level >2 mmol/L after adequate fluid resuscitation (generally recognized at 30 ml/kg crystalloid unless contraindicated as deemed by treating clinician) within the first three hours.
The exclusion criteria are: age < 18 years, pregnant, patients with limitation of care (i.e. do not resuscitate [DNR]), known Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, and vasopressor use for > 24 hours prior to study enrollment.
Patients in Arm 1 will randomized to receive usual care + hydrocortisone, thiamine and ascorbic acid. Arm 2 will be randomized to receive usual care alone. Crossover is not allowed. If a patient is randomized into study Arm 2, the treating physician may decide to administer study medications if they feel it is in the best interest of the patient. In this case the patient will continue to be analyzed in their assigned arm on an intention to treat basis. Source of participants will be in-hospital and Emergency Department patients.
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
- •Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
- •SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
- •Vasopressor required to maintain MAP ≥ 65 AND
- •Serum lactate level >2.0 mmol/L
- •Age ≥ 18 years
- •Non-pregnant
- •Ability to consent with medical capacity or legally authorized representative (LAR) consent
排除标准
- •Age < 18 years
- •Pregnant defined by negative serum HCG in all females
- •Patients with limitation of care (i.e. DNR)
- •Known G6PD deficiency
- •Excluding primary admission diagnosis including the following:
- •Acute stroke
- •Acute coronary syndrome
- •Active gastrointestinal bleed
- •Prisoners
- •>1 episode of sepsis in hospital admission
- •Vasopressor use prior to randomization for more than 24 hours
研究组 & 干预措施
Arm 1: Intervention
Arm will be those that are randomized to receive usual care plus hydrocortisone, thiamine and ascorbic acid.
干预措施: STASIS (Drug)
结局指标
主要结局
In-hospital or 28-day mortality rate
时间窗: 28 days or discharge (whichever comes first)
To determine if the addition of hydrocortisone, thiamine and ascorbic acid to standard care versus standard care in septic shock confers an in-hospital and 28-day mortality benefit
次要结局
- ICU length-of-stay(90 days or discharge (whichever comes first))
- Illness Severity (Change in SOFA Score)(72 hours)
- Hospital length-of-stay ICU LOS Duration of intubation(1 year or discharge (whichever comes first))
- Vasopressor duration (days)(28 days or discharge (whichever comes first))
- Mechanical ventilation(28 days or discharge (whichever comes first))
- Cardiac arrest(28 days or discharge (whichever comes first))
- Procalcitonin(28 days or discharge (whichever comes first))
- ICU delerium (CAM-ICU score)(28 days or discharge (whichever comes first))
- C-reactive protein(28 days or discharge (whichever comes first))
- Renal replacement therapy(28 days or discharge (whichever comes first))
研究者
Amir Vahedian-Azimi
Principle Investigator, Associate Professor
Baqiyatallah Medical Sciences University