Daridorexant to Prevent Post-cardiotomy Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Daridorexant 50 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Cognitive Decline, Postoperative Delirium. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
Overview
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.
Interventions
- Drug Daridorexant 50 mg
Administered consistent with labeling from the US Food and Drug Administration. - Other Placebo
Identical appearing to daridorexant
Primary outcome measures
- Delirium incidence and severity [Time frame: Postoperative Days 1-3]
Secondary outcome measures (1)
- Postoperative sleep quality [Time frame: Postoperative Nights 1-3]
Eligibility criteria
Inclusion criteria
- ≥ 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07217912 · STUDY000010860