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

Primary Purpose

Cognitive Decline, Heart Diseases, Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Regular insulin
Normal Saline Flush, 0.9% Injectable Solution
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

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

    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 POD 7

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

    Outcomes

    Primary Outcome Measures

    Confusion Assessment method for the ICU
    Post Operative Delirium
    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

    Stropp 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
    October 10, 2017
    Last Updated
    January 25, 2021
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03324867
    Brief Title
    The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.
    Official Title
    The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

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

    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
    Cognitive Decline, Heart Diseases, Delirium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    316 (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 POD 7
    Arm Title
    Intranasal Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Normal Saline via nose Before surgery and everyday after surgery up to POD 7
    Intervention Type
    Drug
    Intervention Name(s)
    Regular insulin
    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
    Intervention Description
    Placebo: 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
    Post Operative Delirium
    Time Frame
    an average of 5 days
    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
    Stropp 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
    Ext
    64275
    Email
    hiroaki.sato2@mcgill.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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