Effect of Minocycline on Delirium Incidence in Critically Ill Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Delirium and subsyndromal delirium incidence during ICU stay
研究概览
简要总结
Delirium is a disorder of consciousness characterized by an acute onset and fluctuating course of impaired cognitive functioning. It is associated with unfavorable outcomes in hospitalized patients, including longer hospital length of stay, need for subsequent institutionalization and higher mortality rates. Patients in the intensive care unit (ICU) under mechanical ventilation and older age are at higher risk for the development of delirium. Several studies suggest that minocycline, through its anti-inflammatory effect, was able to prevent neuronal dysfunction in different models of ICU-related diseases. Thus, the present study aimed to evaluate the effect of minocycline on delirium development in critically ill patients. Patients will be randomized into one of two groups: the intervention group that will receive 100mg of minocycline 2 times a day and the placebo group. Medication or placebo will be continued for 28 days or until ICU discharge (whichever occurs first). Delirium will be diagnosed by the CAM-ICU. Coma will be defined by the Richmond Agitation-Sedation Scale (RASS) score of -4 or -5 and biomarkers will be used as alternative outcomes related to the pathophysiology of the disease (IL-1, IL-6, IL-10, and BDNF).
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)
盲法说明
Placebo capsules looking identical to minocycline capsules
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
- •Clinical or surgical patients,
- •Over 18 years,
- •Expected ICU stay of at least 2 days estimated by the attending intensivist,
- •Agree to participate in the study
排除标准
- •Delirium prior to inclusion,
- •Diagnosis of Parkinson's disease
- •Diagnosis of dementia,
- •Alcohol abuse history,
- •Acute neurological condition at admission
- •History of psychiatric disease
- •Use of antipsychotics
- •Pregnant or breastfeeding women,
- •Expectation of death within 2 days
- •Hospitalized for exclusive palliative care
- •Known allergy to minocycline
研究组 & 干预措施
Minocycline
Minocycline 100 mg BID
干预措施: Minocycline (Drug)
Placebo
Placebo capsules identical to experimental arm
干预措施: Placebos (Drug)
结局指标
主要结局
Delirium and subsyndromal delirium incidence during ICU stay
时间窗: up to 28 days
Number of patients with delirium
次要结局
- Days in delirium during ICU stay(up to 28 days)
- Length of ICU stay(up to 28 days)
- Long-term quality of life measured by the 12-Item Short-Form Health Survey V2(until 12 months after hospital discharge)
- Long-term cognitive dysfunction measured by Montreal Cognitive Assessment score(until 12 months after hospital discharge)
- Coma-delirium free days during ICU stay(up to 28 days)
- Length of mechanical ventilation during ICU stay(up to 28 days)
- Long-term depression and anxiety symptoms measured by Hospital Anxiety and Depression Scale(until 12 months after hospital discharge)
- ICU mortality(up to 28 days)
- Hospital mortality(up to 90 days)
- Plasma levels of interleukin-6, interleukin-10, brain derived neural factor and S100-B(At Day 1 and 3 of ICU stay, and hospital discharge)
- Long-term Post-Traumatic Stress Disorder measured by Impact of Event Scale-Revised(until 12 months after hospital discharge)
研究者
Felipe Dal Pizzol
Head, Intensive Care Unit, São José Hospital. Head, Pathophysiology Laboratory, Universidade do Extremo Sul Catarinense
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude