Cognitive DeclineNCT03324867
The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery.
A study testing Regular insulin and Normal Saline Flush, 0.9% Injectable Solution in people with Cognitive Decline and Heart Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Decline, Heart Diseases, Delirium
- What is being tested?
- Regular insulin and Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective open heart surgery requiring cardiopulmonary bypass
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Intranasal Insulin Administration on Cognitive Function 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.
- Conditions
- Cognitive Decline, Heart Diseases, Delirium
- Being tested
- Regular insulin, Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Cognitive Dysfunction, Heart Diseases, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular insulinDrug
Also called Humulin R
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 SolutionDrug
Placebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Insulin 40 IU | Experimental | 40 IU of Humulin-R via nose Before surgery and everyday after surgery up to POD 7 Receives: Drug: Regular insulin |
| Intranasal Normal Saline | Placebo comparator | Normal Saline via nose Before surgery and everyday after surgery up to POD 7 Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confusion Assessment method for the ICU
Post Operative Delirium
Measured: an average of 5 days
Rey Auditory Verbal Leaning
Episodic Memory Lowest score: 0 Highest Score: 15
Measured: up to 12 month
Rey-Osterrieth Complex Figure Test:
Episodic Memory Lowest score: 0 Highest Score: 8
Measured: up to 12 month
Secondary outcomes (6)
Stropp Test
Executive Function
Measured: up to 12 month
Trail Making Test
Executive Function
Measured: up to 12 month
Tower of London test
Executive Function
Measured: up to 12 month
Symbol Digit Modalities Test
Information Processing Speed
Measured: up to 12 month
Boston Naming Test
Language Lowest score: 0 Highest score: 60
Measured: up to 12 month
Clock Drawing Test
Visuospatial Function Lowest score: 1 Highest score: 10
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroaki Sato, MD., PhD., McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324867
- Sponsor's protocol ID
- 2018-3964
- Status last verified
- Jan 2021
- First submitted
- 10 Oct 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Insulin Administration on Cognitive Function After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03324867
- Acronym / sponsor ID
- 2018-3964
- Conditions
- Cognitive Decline, Heart Diseases, Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Insulin 40 IU | Experimental | Drug: Regular insulin40 IU of Humulin-R via nose Before surgery and everyday after surgery up to POD 7 |
| Intranasal Normal Saline | Placebo comparator | Drug: Normal Saline Flush, 0.9% Injectable SolutionNormal Saline via nose Before surgery and everyday after surgery up to POD 7 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective open heart surgery requiring cardiopulmonary bypass
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular insulinAlso: Humulin R40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery. | Drug | Intranasal Insulin 40 IU |
| Normal Saline Flush, 0.9% Injectable SolutionPlacebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery | Drug | Intranasal Normal Saline |
Primary outcome
Confusion Assessment method for the ICU
Time frame: an average of 5 days
Post Operative Delirium
Rey Auditory Verbal Leaning
Time frame: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 15
Rey-Osterrieth Complex Figure Test:
Time frame: up to 12 month
Episodic Memory Lowest score: 0 Highest Score: 8
6 secondary outcomes
Stropp Test
Time frame: up to 12 month
Trail Making Test
Time frame: up to 12 month
Tower of London test
Time frame: up to 12 month
Symbol Digit Modalities Test
Time frame: up to 12 month
Boston Naming Test
Time frame: up to 12 month
Clock Drawing Test
Time frame: up to 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Regular insulin and Normal Saline Flush, 0.9% Injectable Solution in people with Cognitive Decline and Heart Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Schricker, M.D., PhD. (5149341934, thomas.schricker@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confusion Assessment method for the ICU (time frame: an average of 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.