The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.

NCT ID: NCT03324867

Last Updated: 2021-01-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2023-04-30

Brief Summary

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Decline in cognitive function after surgery occurs most commonly in older patients and patients undergoing major surgeries, such as heart surgery. Postoperative Cognitive Dysfunction (POCD) may last a prolonged period of time while Postoperative Delirium (POD) is a more acute disturbance in attention, awareness and cognition. The cause of POCD and POD are not fully understood, however some of the pathophysiology of POCD is similar to that of Alzheimer's disease (AD).

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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Cognitive Decline Heart Diseases Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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 POD 7

Group Type EXPERIMENTAL

Regular insulin

Intervention Type DRUG

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 POD 7

Group Type PLACEBO_COMPARATOR

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type DRUG

Placebo: 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

40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.

Intervention Type DRUG

Normal Saline Flush, 0.9% Injectable Solution

Placebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery

Intervention Type DRUG

Other Intervention Names

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Humulin R

Eligibility Criteria

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Inclusion Criteria

• elective open heart surgery requiring cardiopulmonary bypass

Exclusion Criteria

* inability to provide informed consent
* allergy to insulin
* pregnancy
* mother tongue other than English or French
* visual or hearing impairment interfering with the ability to complete cognitive tests.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Hiroaki Sato, MD., PhD.

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Thomas Schricker, M.D., PhD.

Role: CONTACT

5149341934

Hiroaki Sato, M.D., PhD.

Role: CONTACT

5149341934 ext. 64275

Other Identifiers

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2018-3964

Identifier Type: -

Identifier Source: org_study_id

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