Not Yet RecruitingPhase 2/3

Intranasal Insulin to Prevent Intensive Care Unit Delirium

Netherlands30 participantsStarted 2026-04-15

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 range65 Years

SexALL

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

Trial details

NCT IDNCT07532577

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

Contact for this trial

Rens Kooken, MD

+3124361673 rens.kooken@radboudumc.nl

View on ClinicalTrials.gov More Delirium - Postoperative trials

Who can participate

Age range65 Years

SexALL

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