A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery (PROTEX): A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
详细描述
Purpose:
This is a pilot study to determine the feasibility of a larger randomized controlled trial comparing lemborexant to placebo in patients following cardiac surgery. The primary outcome of this feasibility study is to determine the rate of enrolment, adherence and retention of patients. Secondary outcomes will include incidence of postoperative delirium, delirium days, quality of sleep, hospital length of stay, and the safety and adverse side effect profile of Lemborexant.
Hypothesis:
- Primary outcome: It is feasible to perform a study of lembrorexant versus placebo in patients after cardiac surgery, as defined by achieving a recruitment rate of at least 70% and adherence rate of 80% to the study protocol and drug administration schedule.
Justification:
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
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to hospital following open cardiac surgery through midline sternotomy
排除标准
- •● Known severe obstructive sleep apnea diagnosed by polysomnography or STOPBANG score > 5
- •Periodic limb movement disorder or restless legs syndrome
- •Narcolepsy
- •Somnolence (Pasero Opioid Sedation Scale (POSS) >2)
- •Current alcohol or substance use disorder as defined by the DSM-V
- •Patient already taking moderate or strong CYP3A inhibitors
- •Frequent use of medications for insomnia defined as >4 days per week.
- •Liver failure (Child-Pugh score B or C)
- •Renal failure (eGFR<30 ml/min/1.73 m2)
- •Pre-existing delirium (ICDSC score >3 or CAM/CAM-ICU positive) at time of consent
- •BMI>40 kg/m2
- •Known allergy or hypersensitivity to study drug
- •Inability to communicate in English
研究组 & 干预措施
Intervention
The intervention arm will receive the study drug, Lemborexant 5mg, daily for 7 days post-operatively while in hospital.
干预措施: Lemborexant 5 mg (Drug)
Control
The Control arm will receive the placebo study drug daily for 7 days post-operatively while in hospital.
干预措施: Control (placebo) group (Drug)
结局指标
主要结局
Recruitment Feasibility
时间窗: Prior to Surgery, for the duration of the study recruitment period, estimated to be approximately 2 years
Recruitment will be deemed feasible if the investigators are able to achieve a minimum recruitment rate of 2 patients per week, with 80% of eligible patients approached consenting to participate.
Data Collection Adherence
时间窗: Post-operative day 0 to 7
Data collection adherence will be defined as 80% completion of delirium screening and sleep scores
次要结局
- Incidence of Postoperative Delirium(Post-operative day 0 at baseline (immediately before administration of the drug/placebo) and every 12 hours following drug/placebo administration until end of the 7 day follow-up)
- Delirium Days(Post-operative day 0 to 7)
- Adverse side effects(At the time of study drug initiation (T0) and daily following drug/placebo administration (T1 onwards) until end of the 7 day study follow-up.)
- Sleep Quality(Preoperative baseline (time of recruitment/consent T -1), and daily following drug/placebo administration (T1 onwards) until end of the 7 day follow-up.)
- Incidence of Additional Sleep Medications(Post-operative day 0 to 7)
- Postoperative Hospital Length of Stay(Postoperative day 0 until hospital discharge, usually about 5-7 days postoperatively)
- In-Hospital Mortality(from postoperative day 0 to hospital discharge, usually 5-7 days postoperatively)
研究者
Ron Ree
Clinical Associate Professor
University of British Columbia