Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Hospital Mortality
研究概览
简要总结
Preliminary studies show that giving a "cocktail" of intravenous vitamin C, vitamin B1, and steroids to critically ill patients with septic shock may dramatically improve mortality in those patients. These studies suffer from inadequate design due to lack of controls and blinding to prove the causal effect. Our goal is to conduct a prospective blinded randomized control trial to investigate whether this intervention truly effect outcomes.
详细描述
This is a double-blind randomized placebo controlled study. Only the dispensing pharmacist, who has no clinical interaction with the patient and is not part of the bedside treatment team, will be aware of the treatment allocation. Patients will be randomized into one of 2 groups: the intervention group and the control group. Intervention group will receive intravenous vitamin C and thiamine according to the dosing regimen described below. The control group will receive placebo that is prepared to look identical to the medications within the intervention group.
Randomization will be performed using a random number table generated by the dispensing pharmacist using randomization software. The software will generate subject Identification numbers (IDs) from 1 to 130 and randomize half of the IDs to the control and half to the treatment group. The table will be generated prior to enrollment of the first participant. Once enrollment begins, each participant's medical record number (MRN) will be assigned to the subject IDs in sequential order from 1 to 130. This process will be triggered by the fellow ordering the vitamin C protocol. Only the pharmacist will have access to the table(which will be stored securely) until completion of the study.
The hydrocortisone, vitamin C, thiamine, and their corresponding placebos will be formulated as follows:
Vitamin C: Vitamin C is provided by the manufacturer as a 50ml vial at a concentration of 500mg/ml. Three (3) ml of vitamin C will be placed in a 50 ml bag of Normal Saline (1500mg vitamin C in 50ml bag) which will then be infused over 1 hour. The bag will be labeled by the pharmacy as Vitamin C. The dosing schedule is 1500mg every 6 hours for 4 days or until discharge from the ICU.
Vitamin C placebo will consist of an identical bag of 50cc normal saline (but with no vitamin C) and will be labelled vitamin C. Placebo will be infused over 30-60 minutes as per the infusion instructions of the active vitamin.
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)
盲法说明
Pharmacist who prepares the medication is in charge of blinding randomization.
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 admitted to medical intensive care unit (MICU) for less than 24 hours, who are hypotensive despite a fluid bolus of 30 mL/kg and who are requiring pressors to keep MAP > 65 of at least 5 mcg/min of levophed or equivalent and whose shock is clinically suspected to be secondary to sepsis.
- •In addition, stress dose corticosteroids, hydrocortisone 50mg IV Q6hrs, will have to have been started or intended to be started.
排除标准
- •Contraindication to corticosteroids, thiamine, or vitamin C
- •Treating physician opposed to administering corticosteroids to the patient
- •Age < 18 years
- •Pregnancy
- •DNR/DNI/limitations of care
- •Patients with a fatal underlying disease who are unlikely to survive to hospital discharge
- •Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma
- •Requirement for immediate surgery
- •Patients with HIV and a CD4 < 50 mm2
- •Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.8
- •Involvement in another clinical trial
研究组 & 干预措施
Vitamin C and Thiamine
IV vitamin C, 1500mg in 50ml of normal saline every six hours, infused over one hour and IV Thiamine 200mg in 50ml of 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.
干预措施: Vitamin C (Drug)
Placebo
50ml of IV normal saline every six hours and 50ml of IV 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.
干预措施: Normal saline (Drug)
结局指标
主要结局
Hospital Mortality
时间窗: All Cause in Hospital Mortality average 30 days
In Hospital Mortality
次要结局
未报告次要终点
研究者
Liam Gross
Instructor of Clinical Medicine, Principle Investigator
New York Presbyterian Brooklyn Methodist Hospital