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Effect of Intranasal Insulin on POCD and POD

Primary Purpose

Delirium, Heart Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Regular Insulin, Human 100 UNT/ML
Normal Saline Flush, 0.9% Injectable Solution
Sponsored by
Hiroaki Sato, MD., PhD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Victoria Hospital McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intranasal Insulin 40 IU

Intranasal Normal Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Confusion Assessment method for the ICU
Postoperative Delirium is assessment
Rey Auditory Verbal Leaning
Episodic Memory Lowest score: 0 Highest Score: 15
Rey-Osterrieth Complex Figure Test
Episodic Memory Lowest score: 0 Highest Score: 8

Secondary Outcome Measures

Stroop Test
Executive Function
Trail Making Test
Executive Function
Tower of London test
Executive Function
Symbol Digit Modalities Test
Information Processing Speed
Boston Naming Test
Language Lowest score: 0 Highest score: 60
Clock Drawing Test
Visuospatial Function Lowest score: 1 Highest score: 10

Full Information

First Posted
January 23, 2018
Last Updated
October 13, 2021
Sponsor
Hiroaki Sato, MD., PhD.
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1. Study Identification

Unique Protocol Identification Number
NCT03415061
Brief Title
Effect of Intranasal Insulin on POCD and POD
Official Title
Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hiroaki Sato, MD., PhD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Heart Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
494 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal Insulin 40 IU
Arm Type
Experimental
Arm Description
40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 7
Arm Title
Intranasal Normal Saline
Arm Type
Placebo Comparator
Arm Description
Normal Saline via nose Before surgery and everyday after surgery up to postoperative day 7
Intervention Type
Drug
Intervention Name(s)
Regular Insulin, Human 100 UNT/ML
Other Intervention Name(s)
Humulin R
Intervention Description
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
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Other Intervention Name(s)
Placebo
Intervention Description
Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
Primary Outcome Measure Information:
Title
Confusion Assessment method for the ICU
Description
Postoperative Delirium is assessment
Time Frame
Up to 7 days after surgery
Title
Rey Auditory Verbal Leaning
Description
Episodic Memory Lowest score: 0 Highest Score: 15
Time Frame
up to 12 month
Title
Rey-Osterrieth Complex Figure Test
Description
Episodic Memory Lowest score: 0 Highest Score: 8
Time Frame
up to 12 month
Secondary Outcome Measure Information:
Title
Stroop Test
Description
Executive Function
Time Frame
up to 12 month
Title
Trail Making Test
Description
Executive Function
Time Frame
up to 12 month
Title
Tower of London test
Description
Executive Function
Time Frame
up to 12 month
Title
Symbol Digit Modalities Test
Description
Information Processing Speed
Time Frame
up to 12 month
Title
Boston Naming Test
Description
Language Lowest score: 0 Highest score: 60
Time Frame
up to 12 month
Title
Clock Drawing Test
Description
Visuospatial Function Lowest score: 1 Highest score: 10
Time Frame
up to 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Schricker, M.D., PhD.
Phone
5149341934
Email
thomas.schricker@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroaki Sato, M.D., PhD.
Phone
5149341934
Email
hiroaki.sato2@mcgill.ca
Facility Information:
Facility Name
Royal Victoria Hospital McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Sato, M.D.PhD
Phone
5149341934
Ext
64275
Email
tamaki.sato@muhc.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Hiroaki Sato, M.D.PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Intranasal Insulin on POCD and POD

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