CompletedPhase 2/3

Intranasal Insulin to Prevent Intensive Care Unit Delirium

Netherlands30 participantsStarted 2026-04-30

Plain-language summary

This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥65 years
. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
. Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
. Informed consent from patient

Exclusion criteria

. Delirium at hospital admission
. Non-complex or off-pump cardiac surgery
. Known allergy/hypersensitivity to insulin or formulation excipients
. Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
. Participating in other investigational medication trial

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility: rate of recruitment

Timeframe: From start of study to end of study, with a maximum of 12 months

Feasibility: protocol adherence

Timeframe: From start of treatment up to a maximum of 5 days

Feasibility: participant retention and follow-up completeness

Timeframe: From start of study to end of study, with a maximum of 12 months

Tolerability

Timeframe: From start of treatment up to a maximum of 5 days

Exploratory efficacy

Timeframe: From start of treatment up to a maximum of 7 days

Trial details

NCT IDNCT07532577

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

View on ClinicalTrials.gov More Delirium - Postoperative trials

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥65 years
. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG
. Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
. Informed consent from patient

Exclusion criteria

. Delirium at hospital admission
. Non-complex or off-pump cardiac surgery
. Known allergy/hypersensitivity to insulin or formulation excipients
. Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
. Participating in other investigational medication trial

What they're measuring

Feasibility: rate of recruitment

Timeframe: From start of study to end of study, with a maximum of 12 months

Feasibility: protocol adherence

Timeframe: From start of treatment up to a maximum of 5 days

Feasibility: participant retention and follow-up completeness

Timeframe: From start of study to end of study, with a maximum of 12 months

Tolerability

Timeframe: From start of treatment up to a maximum of 5 days

Exploratory efficacy

Timeframe: From start of treatment up to a maximum of 7 days