DeliriumNCT03415061
Effect of Intranasal Insulin on POCD and POD
A study testing Regular Insulin, Human 100 UNT/ML and Normal Saline Flush, 0.9% Injectable Solution in people with Delirium and Heart Diseases, run by Hiroaki Sato, MD., PhD. at 1 site in Canada.
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
- Delirium, Heart Diseases
- What is being tested?
- Regular Insulin, Human 100 UNT/ML 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
- 494 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 30 Nov 2024
- 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
1 site in 1 country.
Canada1 site
Royal Victoria Hospital McGill University Health Centre
Montreal, Quebec, H4A3J1
Hiroaki Sato, M.D.PhD, 5149341934 ext. 64275, tamaki.sato@muhc.mcgill.ca
Hiroaki Sato, M.D.PhD
About this study
Official title: 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.
- Conditions
- Delirium, Heart Diseases
- Being tested
- Regular Insulin, Human 100 UNT/ML, Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Delirium, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Insulin, Human 100 UNT/MLDrug
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
Also called 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 postoperative day 7 Receives: 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 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
Postoperative Delirium is assessment
Measured: Up to 7 days after surgery
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)
Stroop 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 Jan 2018
- Study start1 Nov 2021 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- 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
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroaki Sato, MD., PhD.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hiroaki Sato, MD., PhD., McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415061
- Sponsor's protocol ID
- 20184334
- Status last verified
- Oct 2021
- First submitted
- 23 Jan 2018
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intranasal Insulin Administration Reduce the Incidence of Cognitive Dysfunction After Cardiac Surgery?
- ClinicalTrials.gov ID
- NCT03415061
- Acronym / sponsor ID
- 20184334
- Conditions
- Delirium, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Hiroaki Sato, MD., PhD.University, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 30 Jan 2018 (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 Insulin, Human 100 UNT/ML40 IU of Humulin-R via nose Before surgery and everyday after surgery up to postoperative day 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 postoperative day 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 Insulin, Human 100 UNT/MLAlso: 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 SolutionAlso: PlaceboNormal 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: Up to 7 days after surgery
Postoperative Delirium is assessment
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
Stroop 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 21 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Insulin, Human 100 UNT/ML and Normal Saline Flush, 0.9% Injectable Solution in people with Delirium and Heart Diseases, run by Hiroaki Sato, MD., PhD. at 1 site in Canada.
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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Up to 7 days after surgery). 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 21 Oct 2021.