Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Delirium incidence and severity
研究概览
简要总结
The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.
Participants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.
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
Study drug and placebo will be identical in appearance, labeling, and administration schedule. Randomization and treatment assignment will be managed by the investigational pharmacy. The blind will be maintained for participants, care providers, investigators, and outcome assessors, and will be broken only after data lock or in the event of a medical emergency.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 yrs;
- •having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;
- •can provide consent;
- •able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);
- •family member or close friend for collateral.
排除标准
- •Prior cardiotomy
- •Infectious endocarditis
- •Emergency surgery
- •Delirium at baseline (positive 3D-CAM)
- •Auditory or visual impairment that prevents study procedures
- •Alcohol or substance misuse (CAGE-AID score ≥ 2)
- •Psychotic disorder
- •Dementia-level deficits (TICS < 27)
- •Use of a prescription sleep aid at least every other night
- •Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)
- •Daridorexant intolerance
- •Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault <30 mL/min, or on dialysis)
- •Narcolepsy
- •Suicidal ideation at baseline
- •Any condition that, in the PI's opinion, compromises patient safety or data quality
- •Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery
研究组 & 干预措施
daridorexant
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
干预措施: Daridorexant 50 mg (Drug)
placebo
Oral matching placebo each of the first three nights after heart surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Delirium incidence and severity
时间窗: Postoperative Days 1-3
Participants will be assessed on postoperative days 1-3 using the Delirium Rating Scale, Revised-98 (DRS-R98; range 0-39; higher scores indicate greater severity of delirium symptoms) and 3-minute Diagnostic interview for the Confusion Assessment Method (3D-CAM; 22 dichotomous items used to inform delirium status). Delirium diagnosis is defined per Diagnostic and Manual of Mental Disorders, 5th Edition, Text Revision, and its severity defined as the sum of DRS-R98 score on postoperative days 1-3.
次要结局
- Postoperative sleep quality(Postoperative Nights 1-3)
研究者
Mark Oldham
Associate Professor of Psychiatry
University of Rochester