Effect of Intranasal Insulin on POCD and POD

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Diseases; Delirium
• Intervention / Treatment: Drug: Regular Insulin, Human 100 UNT/ML; Drug: Normal Saline Flush, 0.9% Injectable Solution

• Study Type: Interventional
• Enrollment (Anticipated): 494
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Schricker, M.D., PhD.; Phone Number: 5149341934; Email: thomas.schricker@mcgill.ca
• Study Contact Backup: Name: Hiroaki Sato, M.D., PhD.; Phone Number: 5149341934; Email: hiroaki.sato2@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A3J1
      • Royal Victoria Hospital McGill University Health Centre
      • Contact: Hiroaki Sato, M.D.PhD; Phone Number: 64275 5149341934; Email: tamaki.sato@muhc.mcgill.ca
      • Principal Investigator: Hiroaki Sato, M.D.PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal Insulin 40 IU; 40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7	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.; Other Names: Humulin R
Placebo Comparator: Intranasal Normal Saline; Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7	Drug: 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 Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rey Auditory Verbal Leaning	Episodic Memory Lowest score: 0 Highest Score: 15	up to 12 month
Confusion Assessment method for the ICU	Postoperative Delirium is assessment	Up to 7 days after surgery
Rey-Osterrieth Complex Figure Test	Episodic Memory Lowest score: 0 Highest Score: 8	up to 12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trail Making Test	Executive Function	up to 12 month
Tower of London test	Executive Function	up to 12 month
Symbol Digit Modalities Test	Information Processing Speed	up to 12 month
Boston Naming Test	Language Lowest score: 0 Highest score: 60	up to 12 month
Clock Drawing Test	Visuospatial Function Lowest score: 1 Highest score: 10	up to 12 month
Stroop Test	Executive Function	up to 12 month

Collaborators and Investigators

• Sponsor: Hiroaki Sato, MD., PhD.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 20184334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No