A Randomised, Placebo Controlled Clinical Trial of Dexmedetomidine as Part of a Sleep Promotion Bundle to Improve Sleep in Intensive Care
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Recruitment rate
研究概览
简要总结
Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory.
To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital.
The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day.
To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers.
This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured.
It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.
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, 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
- •Adult patient aged 18 years old or over admitted to the ICU
- •Anticipated to stay in the ICU for another 48 hours after the first sleep recording
- •Mechanically ventilated or on high flow oxygen (Optiflow)
- •Hemodynamically stable
- •Conscious, non-sedated patient with capacity to complete a self-reported sleep assessment*
排除标准
- •Contraindication to dexmedetomidine (including but not limited to allergy and bradycardia [heart rate < 50 beats per minute])
- •Currently receiving dexmedetomidine or other alpha-2 agonists (e.g., clonidine)
- •Patients with structural neurological disease (e.g., stroke or tumor or traumatic brain injury) or degenerative neurologic disease (e.g., Parkinson's disease or dementia) and GCS < 14
- •Patients with second- or third-degree heart block (unless pacemaker implanted)
- •Patients with clinically significant hepatic or renal disease
- •Patients with limitations in therapy or actively being palliated
- •Patients with primary psychiatric disorder (e.g., new diagnosis of or uncontrolled schizophrenia, severe depression)
- •Patients experiencing substance intoxication or withdrawal (e.g., severely agitated delirium)
- •Patients participating in other studies involving the use of pharmacologically active substances
- •Treating clinician believes study participation is not in the patient's best interest
- •Pregnancy or breastfeeding
研究组 & 干预措施
Control
Patients randomized to the control group will receive a placebo daily for 2 consecutive nights.
干预措施: Control (placebo) group (Other)
Intervention
Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (optiflow) and intubated patients with delirium as part of routine care.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 2 years
Rate of recruitment: The investigators will consider the main trial to be feasible if a recruitment rate of at least 1 patient per month per participating site is achieved. The investigators will report recruitment rates with 95% confidence intervals.
次要结局
- Protocol Adherence(2 years)