Effect of Intranasal Insulin on POCD and POD

Heart Diseases Clinical Trial

Official title:

Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03415061
• Other study ID #: 20184334
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Thomas Schricker, M.D., PhD.
• Phone: 5149341934
• Email: thomas.schricker[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 494
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Heart Diseases

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hiroaki Sato, MD., PhD.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confusion Assessment method for the ICU	Postoperative Delirium is assessment	Up to 7 days after surgery
Primary	Rey Auditory Verbal Leaning	Episodic Memory Lowest score: 0 Highest Score: 15	up to 12 month
Primary	Rey-Osterrieth Complex Figure Test	Episodic Memory Lowest score: 0 Highest Score: 8	up to 12 month
Secondary	Stroop Test	Executive Function	up to 12 month
Secondary	Trail Making Test	Executive Function	up to 12 month
Secondary	Tower of London test	Executive Function	up to 12 month
Secondary	Symbol Digit Modalities Test	Information Processing Speed	up to 12 month
Secondary	Boston Naming Test	Language Lowest score: 0 Highest score: 60	up to 12 month
Secondary	Clock Drawing Test	Visuospatial Function Lowest score: 1 Highest score: 10	up to 12 month