A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sequential organ function assessment score (SOFA)
研究概览
简要总结
This study is designed to determine if Vitamin C administration to septic patients will result in an improvement in organ dysfunction which occurs during a septic illness.
Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce the length of time on a ventilator, length of stay in the intensive care unit and in hospital.
详细描述
This study will measure biomarkers of inflammation, coagulation and oxidative stress. These biomarkers have been shown to be increased during periods of oxidative stress eg post-operative, trauma, sepsis. The investigators will determine if Vitamin C administration decreases oxidative stress and as a result, a decrease in the markers of organ dysfunction eg SOFA Scores. Ultimately, if the investigators show a decrease in injury to organs, will this result in a better outcome for 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
- •diagnosis of severe sepsis
- •admitted to the intensive care unit
排除标准
- •allergy to Vitamin C
- •history of kidney stones
- •glucose-6-phosphate dehydrogenase deficiency
- •history of iron overload/hemochromatosis
研究组 & 干预措施
Vitamin C
Intravenous Vitamin C will be administered (1 gram) every 8 hours for 28 days or discharge from intensive care unit
干预措施: Vitamin C (Drug)
placebo
placebo vehicle administered in same fashion as active treatment
干预措施: placebo (Drug)
结局指标
主要结局
Sequential organ function assessment score (SOFA)
时间窗: 28 days or discharge from intensive care unit
Scoring system to determine the extent of a patient's organ function or rate of failure. The score based on 6 different scores; one each for respiratory, hepatic, cardiovascular, renal, coagulation, neurologic.
次要结局
- Biomarkers as a measure of coagulation, inflammation and oxidative stress.(28 days or discharge from intensive care unit)
研究者
Michael Sharpe
Principal Investigator
Lawson Health Research Institute