The Impact of Cytochrome P450 Abnormalities in Patients With Delirium. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- • Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).
研究概览
简要总结
Objectives:
- To examine whether patients with delirium have higher prevalence of cytochrome-P450 abnormalities compared to patients without delirium.
- To examine whether the severity of delirium is related to a specific cytochrome P450 genotype.
- To examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome p450 abnormalities
- To examine whether delirium persistence is impacted by types of medications administered during their hospital stay.
详细描述
Delirium is a costly and devastating illness affecting older patients in the hospital. Its prevalence increases as patients get older and sicker. There is scientific evidence that delirium affects cognitive function for a prolonged period of time and in many cases irreversibly. The economic burden on health care and emotional burden on the caregivers of patients with delirium is tremendous. We think that our study may contribute to developing prevention strategies for delirium in the hospital. We propose genetic testing of older patients to determine their ability to metabolize commonly used medications in the hospital. This will give medical professionals and pharmacists an ability to adjust dosages of medications based on the patient's genetic profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients age 18 and older admitted to the ALGH (Advocate Lutheran General Hospital) rehabilitation unit
- •One or more of the Following Principle Diagnosis:
- •Principle stroke diagnosis Principle Cardiac-Post cardiac surgery Principle Spinal surgery
- •Non-English speakers are not anticipated. However, there is an available interpreter services already on the unit and this interpreter's services will be utilized. https://www.languageline.com/ However, we will utilize that AHC IRB approved short forms if a potential subject presents itself.
排除标准
- •Stroke patients with any diagnosed aphasia
- •Spinal surgery, as a result of trauma
- •Pregnant women
- •Patients with dementia (score of greater than 3.3 on short IQCODE questionnaire) (Long Term Cognitive Impairment after Critical Illness, NEJM, 2013, Pandharipande et al.)
- •Patients with cirrhosis and liver failure
- •Patients with renal failure requiring dialysis
- •Recent blood transfusion
结局指标
主要结局
• Rates of cytochrome P450 in cases (delirium patients) compared to controls (non-delirium patients).
时间窗: 2 years
Statistical Analysis Plan: Descriptive statistics will be presented as mean ± SD for continuous variables and percentage/count for dichotomous/categorical variables. Chi-square test and t-test will be used to compare distribution of variables of interest between the two groups. Logistic regression analysis will be performed to estimate the risk of PEP while adjusting for all potential confounding factors.
次要结局
未报告次要终点