What side effects are associated with this type of intervention?

Common treatments for heart disease include medications such as beta-blockers, ACE inhibitors, statins, and anticoagulants. These treatments can have various side effects. Beta-blockers may cause fatigue, cold hands and feet, and depression. ACE inhibitors can lead to a persistent dry cough, elevated blood potassium levels, and kidney dysfunction. Statins are known for muscle pain, liver damage, and increased blood sugar levels. Anticoagulants can increase the risk of bleeding and bruising. While intranasal insulin is being studied for its cognitive benefits, it is not a standard treatment for heart disease, and its side effects in this context are not well-documented.

What prior FDA approvals exist?

FDA-approved treatments for heart disease include various pharmacologic therapies such as angiotensin-converting enzyme inhibitors, statins like atorvastatin and rosuvastatin, and beta-blockers like metoprolol and carvedilol. These treatments primarily focus on reducing cardiovascular events and managing dyslipidemia. While intranasal insulin is being studied for its potential to improve memory performance and cognitive function postoperatively, it is not yet an FDA-approved treatment for heart disease. Current heart disease treatments do not typically address cognitive function directly.

What other types of research exist?

Promising novel alternatives to intranasal insulin for improving memory performance and cognitive function in heart disease patients include: 1) Memantine, which has been studied for its effects on cognitive function in various types of dementia, including frontotemporal dementia. 2) Antioxidant supplementation, such as Coenzyme Q10, which has shown potential in improving oxidative imbalance and cognitive performance. 3) Emerging pharmacotherapies targeting neurogenesis and cognitive performance, such as those being developed for neurodevelopmental disorders. These alternatives should be discussed with a healthcare provider to determine their suitability and potential benefits for individual patients.

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Hormone Therapy

Intranasal Insulin for Post-Surgery Delirium

N/A

Waitlist Available

Research Sponsored by Hiroaki Sato, MD., PhD.

Eligibility Criteria Checklist

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

Must have

Elective open heart surgery requiring cardiopulmonary bypass

Be older than 18 years old

Must not have

Allergy to insulin

Visual or hearing impairment interfering with the ability to complete cognitive tests.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 month

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing if giving insulin through the nose can help older patients and those having major heart surgery avoid memory and thinking problems after their operation. The idea is that insulin might protect the brain and improve its function. Insulin administered this way has shown potential in improving cognitive function and reducing side effects by directly affecting the brain.

Who is the study for?

This trial is for adults scheduled for elective open heart surgery with cardiopulmonary bypass. Participants must be able to consent, speak English or French, and not have any sensory impairments that affect cognitive testing. It's not suitable for those allergic to insulin or pregnant individuals.

What is being tested?

The study tests if intranasal insulin can improve memory and cognition after heart surgery, aiming to reduce Postoperative Cognitive Dysfunction (POCD) and Delirium (POD). Patients will receive regular human insulin or a saline solution as a comparison.

What are the potential side effects?

Intranasal insulin may cause local irritation in the nose, low blood sugar levels if absorbed systemically, headache, runny nose, or cough. However, since it's administered nasally rather than injected into the bloodstream directly, systemic side effects are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for open heart surgery with a heart-lung machine.

Exclusion Criteria

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

Select...

I am allergic to insulin.

Select...

I have vision or hearing problems that could affect taking tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confusion Assessment method for the ICU

Rey Auditory Verbal Leaning

Rey-Osterrieth Complex Figure Test

Secondary study objectives

Boston Naming Test

Clock Drawing Test

Stroop Test

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intranasal Insulin 40 IUExperimental Treatment1 Intervention

40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7

Group II: Intranasal Normal SalinePlacebo Group1 Intervention

Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart disease include beta-blockers, ACE inhibitors, statins, and antiplatelet agents. Beta-blockers reduce heart rate and blood pressure by blocking adrenaline effects, ACE inhibitors relax blood vessels by inhibiting the angiotensin-converting enzyme, statins lower cholesterol by inhibiting HMG-CoA reductase, and antiplatelet agents prevent blood clots by inhibiting platelet aggregation. These treatments are crucial for heart disease patients as they help manage symptoms, prevent complications, and improve overall cardiovascular health. Similar to intranasal insulin, which improves cognitive function, these treatments can also have secondary benefits, such as reducing the risk of stroke and improving quality of life.

The patient with chronic heart failure undergoing surgery.Effects of oral administration of orodispersible levo-carnosine on quality of life and exercise performance in patients with chronic heart failure.Medical versus interventional management of stable angina.