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Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients

Study acronym: PROTEX
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Jan 15, 2025 to May 1, 2025
    • Primary and study completion dates: Jan 30, 2027 to Apr 30, 2027
    • Collaborators reordered
    v3
  2. Enrollment target: 110 to 60v2 Show 5 more changesShow less
    • Start date: Nov 1, 2024 to Jan 15, 2025
    • Primary completion date: Dec 31, 2026 to Jan 30, 2027
    • Study completion date: Dec 31, 2027 to Jan 30, 2027
    • Secondary endpoints revised (7)
    • Study description shortened, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06648681
Lead Sponsor University of British Columbia
Collaborators: Eisai Inc., Providence Health Care, British Columbia, St. Paul's Hospital, Vancouver (Providence Health Care)
Conditions
(from sponsor)		 Delirium - Postoperative, Cardiac Surgery, Cardiac Surgery Subjects, Orexin Antagonist, Feasibility Studies, Sleep, In-hospital Mortality
Related terms Delirium, Emergence Delirium, Sleep Initiation and Maintenance Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov