A Single Center, Investigator Blinded, Randomized Placebo Control, 24 Month, Parallel Group, Superiority Study to Compare the Efficacy of Thiamine, Vitamin C and Hydrocortisone in the Treatment of Septic Shock.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- The mortality rate comparison of patients with septic shock at Lakeland Regional Medical Center to the study published in CHEST.
研究概览
简要总结
The purpose of this research study is to determine whether patients who receive thiamine (vitamin B1), vitamin C and hydrocortisone while in septic shock have improved outcomes compared to hydrocortisone alone.
A recently published article "Hydrocortisone, Vitamin C and Thiamine for the treatment of Severe Sepsis and Septic Shock," suggested substantial mortality reduction (78%). We wish to test the hypothesis that mortality reduction is at least 25% in a prospective randomized trial. Other important sub-aims include the testing whether the protocol reduces the time on pressors agents, reduces the trajectory of the SOFA score, or reduces the trajectory of procalcitonin.
详细描述
The study has four specific aims. The first is to utilize the Marik protocol published in CHEST to determine mortality reduction in septic shock with thiamine (vitamin B1), vitamin C and hydrocortisone supplementation. The second aim is to determine whether supplementation with thiamine, vitamin C and hydrocortisone reduce time spent on vasopressor support. Thirdly, whether the trajectory of the SOFA score is affected by supplementation with thiamine, hydrocortisone and vitamin C. Fourthly, assess the trajectory of procalcitonin, a laboratory test, in patients treated with the protocol.
This is a single center community based hospital in Southwest Michigan, investigator blinded, randomized placebo controlled trial, 24 month, parallel group, two arm, superiority study with a 1:1 allocation ratio to compare the efficacy of thiamine, vitamin C and hydrocortisone in the treatment of severe sepsis and septic shock. Each arm of the research study will contain 30 patients in order to detect a 25% mortality reduction. Enrollment for this study will be initiated in patients with septic shock that require addition of a second pressor agent. The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care. If the patient needs additional pressor support or therapy, that will be recorded in the results.
The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. If the patient needs additional pressor support or therapy that will be recorded in the results.
To clarify, both arms will utilize two vasopressor agents, hydrocortisone and supportive care, the experimental group will also receive vitamin C and thiamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Eligible patients will be randomized in equal blinded proportions by the pharmacy department to receive thiamine, vitamin C and hydrocortisone in the experimental arm or continue with hydrocortisone plus placebo and usual standard of care treatment as discussed previously.
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
- •Diagnosis of Septic Shock on two vasopressor agents
- •Age between 18-90 years old
- •Ability to provide written informed consent
排除标准
- •Age younger than 18 years old
- •DNR or DNI status with limitations of care, such as "supportive care only"
- •Patients/advocates that request thiamine, vitamin C or hydrocortisone supplementation
研究组 & 干预措施
Placebo Arm
The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care to care for septic shock. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.
Thiamine and Vitamin C administration Arm
The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. The IV bags will be blinded by pharmacy. If the patient needs additional pressor support or therapy, the data will be recorded in the results.
干预措施: Thiamine and Vitamin C (Dietary Supplement)
结局指标
主要结局
The mortality rate comparison of patients with septic shock at Lakeland Regional Medical Center to the study published in CHEST.
时间窗: 24 months
The mortality rate difference between control and experimental arms
次要结局
- The duration on vasopressor support(24 months)
- Quantify the Sequential Organ Failure Assessment score in Septic shock patients requiring vasopressor therapy(24 months)