Daridorexant to Prevent Post-cardiotomy Delirium

Recruiting Phase 2 Interventional Study
Postoperative Cognitive Decline Postoperative Delirium
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
80 (estimated)
Sponsor
University of Rochester · Other
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About This Trial
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 in…
Trial Locations
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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 valid…
Contacts

Mark Oldham, MD

585-275-3592

mark_oldham@urmc.rochester.edu

CONTACT