Study of Dexmedetomidine as an Effective Sedative to Treat Acute ICU Delirium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Resolution of Delirium
研究概览
简要总结
The purpose of the research is to see if dexmedetomidine (a drug that has a calming effect - a sedative) is effective for the treatment of acute delirium
详细描述
Delirium is a mental disturbance that causes people to be confused and restless for a period of time. We will compare dexmedetomidine to the traditional therapy for treatment of acute delirium. Dexmedetomidine does not affect breathing. The traditional drugs might make one sleepy and may slow down breathing. The traditional therapy in this institution for acute delirium is _the use of Haloperidol, and/or benzodiazepines. Haloperidol is an antipsychotic drug that has calming effect. Benzodiazepines are sedatives with calming effect.Dexmedetomidine is approved by the Food and drug Administration (FDA) to sedate patients on a breathing machine for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adults admitted to our surgical ICU who do not have any exclusion criteria
- •Eligibility for treatment- Development of delirium as defined
排除标准
- •Acute MI (myocardial infarction),
- •Trauma <24 hours,
- •Head injury,
- •Multiple organ failure,
- •EF (ejection fraction) < 30%,
- •History of hypersensitivity to alpha2 agonist,
- •History of seizures, MAP (mean arterial pressure) <60 mm of Hg,
- •Dysrhythmias a/with bradycardia (HR (heart rate) <50),
- •Need for vasopressors,
- •Acute renal failure with a need for dialysis/CVVH (Continuous Veno-Venous Hemofiltration) or liver disease.
- •Women of child bearing age who do not have a documented negative pregnancy test and/or who do not actively use contraception. (Documented negative pregnancy test will be a urine pregnancy test obtained on this admission)
研究组 & 干预措施
Infusion of dexmedetomidine
infusion 0.3-0.7 dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Standard of Care
Standard of care per treating physician preference
干预措施: Standard of Care (Other)
结局指标
主要结局
Resolution of Delirium
时间窗: Up to 7 days
Resolution of delirium as defined by 2 consecutive negative CAM-ICU assessments. The Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU assesses the four features of delirium: feature 1 is an acute change in mental status or a fluctuating mental status, feature 2 is inattention, feature 3 is altered level of consciousness, and feature 4 is disorganized thinking.
次要结局
- In-hospital Mortality(Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end)
- Length of Ventilator Support(Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end)
- Length of Intensive Care Unit (ICU) Stay(Patients will remain in the study for up to 7 days after development of delirium or discharge from ICU whichever is earlier, up to study end)
- Ease of Management for the Nursing Staff(Up to initial 48 hours)
研究者
Gerald L. Weinhouse
Staff Physician
Brigham and Women's Hospital