Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Delirium
研究概览
简要总结
Purpose: To conduct a randomized controlled pilot study investigating the use of high dose intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium, including health-related quality of life (HRQOL), functional status, and neuropsychiatric outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic hematopoietic stem cell transplant (HSCT).
Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for allogeneic stem cell transplant.
Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will be measured weekly and participants will be assessed for evidence of delirium using validated measures. Validated measures will also be used to assess cognitive function, depression, post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at one, three, and six months after transplant.
详细描述
Delirium is a common and potentially preventable neuropsychiatric complication in cancer patients receiving hematopoietic stem cell transplantation (HSCT) that has profound consequences. Among cancer patients hospitalized for HSCT, delirium occurs in approximately 40% of patients and increases the risk of mortality. Long-term, delirium in this population results in worse physical health, mental health, and quality of life. Though strategies to prevent delirium have the potential to significantly improve the lives of people living with cancer, research in this area is extremely limited. Thiamine deficiency is also ubiquitous during HSCT and a known contributor to the development of delirium in other patient populations. High dose intravenous (IV) thiamine is an evidence-based and promising treatment for delirium, but no one has studied IV thiamine as a prevention strategy.
This is a randomized double-blind controlled trial in participants undergoing allogeneic HSCT to determine if high dose IV thiamine can prevent delirium and minimize the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and other neuropsychiatric outcomes. The investigators will recruit 60 patients admitted for allogeneic HSCT at UNC, randomize them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluate all participants for delirium and related comorbidities. The investigators will use the Delirium Rating Scale (DRS) to measure the severity and duration of delirium immediately prior to transplant and after HSCT until 30 days post-transplant or discharge. If delirium is identified, the DRS will be administered daily until delirium resolves. The investigators will obtain thiamine levels and other laboratory parameters associated with delirium the day after transplant, and continue to monitor thiamine levels weekly thereafter. The investigators will also monitor HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to transplant and at one, three, and six months after transplant to elucidate the persistent impact of delirium in this population and the potential for thiamine to mitigate these negative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell transplant
- •At least 18 years of age
- •Able to speak English
- •Able to provide informed consent
排除标准
- •A history of adverse reaction to IV thiamine
- •Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
研究组 & 干预措施
Intervention
Thiamine 200 mg IV
干预措施: Thiamine (Drug)
Control
Normal saline IV
干预措施: Normal saline (Drug)
结局指标
主要结局
Percentage of Participants With Delirium
时间窗: Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.
Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of \> 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS \> 12.
次要结局
- Change in Depression Scores (Month 3)(Baseline to three months post-transplant)
- Change in Health-related Quality of Life Scores (Month 6)(Baseline to six months post-transplant)
- Change in Depression Scores (Month 1)(Baseline to one month post-transplant)
- Change in Depression Scores (Month 6)(Baseline to six months post-transplant)
- Change in Post-traumatic Stress Symptom Scores (Month 3)(Baseline to three months post-transplant)
- Concentration of Thiamine Status Stratified by Delirium Status(From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days)
- Change in Health-related Quality of Life Scores (Month 1)(From baseline to one month post-transplant)
- Change in Cognitive Function Scores (Month 1)(From baseline to one month post-transplant)
- Delirium Severity(Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5)
- Delirium Duration(Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.)
- Change in Health-related Quality of Life Scores (Month 3)(Baseline to three months post-transplant)
- Change in Post-traumatic Stress Symptom Scores (Month 6)(Baseline to six months post-transplant)
- Change in Functional Status Scores (Month 3)(From baseline to three months post-transplant)
- Change in Cognitive Function Scores (Month 3)(Baseline to three months post-transplant)
- Change in Functional Status Scores (Month 1)(Baseline to one month post-transplant)
- Change in Post-traumatic Stress Symptom Scores (Month 1)(Baseline to one month post-transplant)
- Change in Cognitive Function Scores (Month 6)(From baseline to six months post-transplant)
- Change in Functional Status Scores (Month 6)(Baseline to six months post-transplant)