Daridorexant for Delirium After Heart Surgery

Phase 2

Waitlist Available

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital

Be older than 18 years old

Must not have

Infectious endocarditis

Prior heart surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first 3 days after surgery (continued up to 1 week if delirious on postop day 3)

Summary

This trial aims to test whether a new drug, daridorexant, can help prevent delirium after heart surgery. The trial will assess if it is possible to recruit participants, administer the

Who is the study for?

This trial is for adults who can consent, undergoing aortic valve replacement or bypass surgery at Strong Memorial Hospital, speak English, and have someone close to help with the study. It's not suitable for those unable to meet these conditions.

What is being tested?

The trial tests if Daridorexant helps prevent confusion or 'brain fog' after heart surgery compared to a placebo. Participants take the drug or placebo for three nights post-surgery and are checked for sleep quality and delirium.

What are the potential side effects?

Potential side effects of Daridorexant may include drowsiness, dry mouth, fatigue, but specific side effects will be monitored during the trial as part of its objectives.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having heart valve or bypass surgery at Strong Memorial Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with infectious endocarditis.

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I have had heart surgery in the past.

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I am currently taking medication that strongly affects liver enzyme activity.

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I require emergency surgery.

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I have severe kidney or liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first 3 days after surgery (continued up to 1 week if delirious on postop day 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first 3 days after surgery (continued up to 1 week if delirious on postop day 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 3 days after surgery (continued up to 1 week if delirious on postop day 3) for reporting.