Thiamine Administration and Prevalence of Delirium in the Intensive Care Unit: A Before-after Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Delirium score
研究概览
简要总结
Delirium is a very common condition among ICU-admitted patients, and its prevalence is estimated between 30-40%. Delirium is associated with increased morbidity and mortality and future cognitive decline, along with increased ventilation-dependency and other complications.
There are multiple risk factors for delirium, including deficiencies of micronutrients. Thiamine deficiency is associated with specific neurological syndromes, including Wernicke and Korsakoff syndromes and Delirium Tremens. Several studies demonstrated significant thiamine deficiency among ICU-admitted patients (prevalence of 30-70%) without known risk factors, such as alcohol dependency. Thiamine deficiency may cause delirium in those patients.
Intravenous thiamine had been safely used for decades, for several indications. Lately, thiamine has been advocated for therapy in patients with septic shock, and its use in intensive care units has increased worldwide.
Since 2016, thiamine has been routinely administered in our intensive care unit. Considering the theoretical association between thiamine deficiency and ICU-related delirium, the investigators aim to investigate whether the routine use of thiamine has been associated with decreased prevalence of delirium among ICU patients when compared to the pre-routine thiamine administration era.
详细描述
Delirium is a very common condition among ICU-admitted patients, and its prevalence is estimated between 30-40%. Delirium is associated with increased morbidity and mortality and future cognitive decline, along with increased ventilation-dependency and other complications.
There are multiple risk factors for delirium, including deficiencies of micronutrients. Thiamine deficiency is associated with specific neurological syndromes, including Wernicke and Korsakoff syndromes and Delirium Tremens. Several studies demonstrated significant thiamine deficiency among ICU-admitted patients (prevalence of 30-70%) without known risk factors, such as alcohol dependency. Thiamine deficiency may cause delirium in those patients.
Intravenous thiamine had been safely used for decades, for several indications. Lately, thiamine has been advocated for therapy in patients with septic shock, and its use in intensive care units has increased worldwide.
Since 2016, thiamine has been routinely administered in our intensive care unit. Considering the theoretical association between thiamine deficiency and ICU-related delirium, the investigators aim to investigate whether the routine use of thiamine has been associated with decreased prevalence of delirium among ICU patients when compared to the pre-routine thiamine administration era.
Primary endpoint: Average delirium score during ICU-hospitalization before and after the routine intravenous thiamine administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients, aged 18-99, admitted to the intensive care unit in our medical facility between the years 2014-2018 (two years before and after intervention).
排除标准
- •Patients who were treated with thiamine prior to ICU admission, and patients who did not receive thiamine in the ICU.
研究组 & 干预措施
Non-thiamine group
group 2: ICU patients who received IV thiamine,100-500 mg/day for at least one day
干预措施: intravenous Thiamine (Drug)
结局指标
主要结局
Delirium score
时间窗: Average RASS score during ICU-hospitalization, through study completion, an average of 1 year
RASS score (Richmond agitation-sedation scale, from minus 5 to plus 4, desirable score 0)
次要结局
未报告次要终点