NCT03415061

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
494

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
3.8 years until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

January 23, 2018

Last Update Submit

October 13, 2021

Conditions

DeliriumHeart Diseases

Outcome Measures

Primary Outcomes (3)

  • Confusion Assessment method for the ICU

    Postoperative Delirium is assessment

    Up to 7 days after surgery

  • 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)

  • Stroop 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

  • +1 more secondary outcomes

Study Arms (2)

Intranasal Insulin 40 IU

EXPERIMENTAL

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

Intranasal Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

Regular Insulin, Human 100 UNT/MLDRUG

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 SolutionDRUG

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

Also known as: Placebo
Intranasal Normal Saline

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

MeSH Terms

Conditions

DeliriumHeart Diseases

Interventions

Insulin

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Thomas Schricker, M.D., PhD.

CONTACT

5149341934thomas.schricker@mcgill.ca

Hiroaki Sato, M.D., PhD.

CONTACT

5149341934hiroaki.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
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

November 1, 2021

Primary Completion

November 30, 2023

Study Completion

November 30, 2024

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)