Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
494 participants
INTERVENTIONAL
2021-11-01
2024-11-30
Brief Summary
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Insulin given intravenously during heart surgery has been shown to preserve short and long-term memory function after the operation. Clinical trials further demonstrated that insulin given via the nose (intranasal) improves memory performance of patients with AD or cognitive impairment suggests that intranasal insulin also could be a therapeutic option for POCD and POD.
This study is designed to examine the effect intranasal insulin on POCD and POD. The goal is to investigate whether administration of intranasal insulin during and after heart surgery improves cognitive function postoperatively.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intranasal Insulin 40 IU
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
Regular Insulin, Human 100 UNT/ML
40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
Intranasal Normal Saline
Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7
Normal Saline Flush, 0.9% Injectable Solution
Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
Interventions
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Regular Insulin, Human 100 UNT/ML
40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
Normal Saline Flush, 0.9% Injectable Solution
Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* allergy to insulin
* pregnancy
* mother tongue other than English or French
* visual or hearing impairment interfering with the ability to complete cognitive tests.
50 Years
ALL
No
Sponsors
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Hiroaki Sato, MD., PhD.
OTHER
Responsible Party
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Hiroaki Sato, MD., PhD.
Assistant Professor
Locations
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Royal Victoria Hospital McGill University Health Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20184334
Identifier Type: -
Identifier Source: org_study_id