Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- ventilation
研究概览
简要总结
Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction.
Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients.
Material and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis.
Ethical license: 7849-PTE 2019.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •septic shock
- •intensive care unit administration
排除标准
- •under age 18
- •above age 80
- •moribund patients
- •pregnant patients
- •active kidney stone
- •inability to obtain consent
- •viral or mixed sepsis
- •missed dose of vitamin C/ thiamin or hydrocortisone
- •Physician refused
- •Vitamin C / Thiamine/ Hydrocortisone for other indications
研究组 & 干预措施
intervention group
Patients in the intervention group (n=23) received the combined vitamin therapy: IV vitamin C (1.5 g every 6 hours administered as an infusion over 30 to 60 minutes and mixed in a 100- mL solution of normal saline), hydrocortisone (100 mg in bolus-100 mg in perfusor up to 60 min (200mg 24h),), and thiamine (200 mg every 12 hours administered as an infusion over 30 to 60 minutes and mixed in a 100-mL solution of normal saline) for 3 days.
干预措施: Vitamin C (Drug)
结局指标
主要结局
ventilation
时间窗: intensive care unit discharge (up to 90 days)
duration of mechanical ventilation (days)
vasopressors
时间窗: intensive care unit discharge (up to 90 days)
length of circulatory support (days)
Length of stay
时间窗: intensive care unit discharge (up to 90 days)
length of Intensive care unit staying (days)
main mortality
时间窗: intensive care unit discharge (up to 90 days)
all-cause mortality (dead/survived) in the intensive care unit
次要结局
- secondary outcomes(up to 5 days after admission to intensive care)
- antibiotics(intensive care unit discharge (up to 90 days))
- PiCCO parameters(up to 5 days after admission to intensive care)
- other mortality's(up to 60 days after admission to intensive care)