Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mortality Rates
研究概览
简要总结
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.
详细描述
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.
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
All parties involved, except for pharmacy personnel will be blinded.
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
- 未提供
排除标准
- •Not diagnosed with severe sepsis or septic shock
- •Younger than 18 or older than 90 years old
- •With a history of nephrolithiasis
- •Who are pregnant
- •Weigh less than 30 kg
- •Not located in the ICU
- •Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
- •Currently on dialysis
研究组 & 干预措施
TREATMENT with Vitamins C and B1
Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
干预措施: Vitamin C (Drug)
TREATMENT with Vitamins C and B1
Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
干预措施: Vitamin B1 (Drug)
结局指标
主要结局
Mortality Rates
时间窗: From time of treatment to 30 days post hospital discharge, up to 87 days.
All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)
次要结局
- Hospital Length of Stay(From admission to the hospital through hospital discharge, up to 57 days.)
- Ventilator Days(From admission to the ICU through discharge from the ICU, up to 25 days.)
- Hours on Vasopressors(From admission to the ICU through discharge from the ICU, up to 25 days.)
- Intensive Care Unit Length of Stay(From time of admission to the ICU through discharge from the ICU, up to 25 days)
- Readmission Rate(30 days after hospital discharge)