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

NCT03324867 | Unknown DMC

• 1 other identifier: 2018-3964
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cognitive Decline; Heart Diseases; Delirium

Outcome Measures

Primary Outcomes (3)

• Confusion Assessment method for the ICU

  Post Operative Delirium

  an average of 5 days

• Rey Auditory Verbal Leaning

  Episodic Memory Lowest score: 0 Highest Score: 15

  up to 12 month

• Rey-Osterrieth Complex Figure Test:

  Episodic Memory Lowest score: 0 Highest Score: 8

  up to 12 month

Secondary Outcomes (6)

• Stropp Test

  up to 12 month

• Trail Making Test

  up to 12 month

• Tower of London test

  up to 12 month

• Symbol Digit Modalities Test

  up to 12 month

• Boston Naming Test

  up to 12 month

Study Arms (2)

Intranasal Insulin 40 IU

EXPERIMENTAL

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

Drug: Regular insulin

Intranasal Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

Regular insulin 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.

Also known as: Humulin R

Intranasal Insulin 40 IU

Normal Saline Flush, 0.9% Injectable Solution DRUG

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

Intranasal Normal Saline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective open heart surgery requiring cardiopulmonary bypass

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Cognitive Dysfunction; Heart Diseases; Delirium

Interventions

Insulin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Thomas Schricker, M.D., PhD.

CONTACT

5149341934; thomas.schricker@mcgill.ca

Hiroaki Sato, M.D., PhD.

CONTACT

5149341934; hiroaki.sato2@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 30, 2017
• Study Start: April 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share