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Insulin nasal spray to prevent delirium after cardiac surgery
EU CTIS ID: 2025-524680-21-00
What this study is testing
This study aims to assess the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥65 years
- Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex surgery is defined as: combined procedures (e.g., multi-vessel CABG or single CABG + valve replace-ment/repair); or aortic surgery (ascending aorta, arch, or root) or repair of aortic dissection; or expected CPB duration ≥ 90 minutes, as estimated preoperatively
- Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- Informed consent from patient
You likely can't join if
- Delirium or dementia present at baseline
- Single-vessel CABG, single valve replacement/repair or off-pump cardiac surgery
- Known allergy/hypersensitivity to insulin or formulation excipients
- Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus sur-gery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.