Intranasal Insulin to Prevent Intensive Care Unit Delirium

Intranasal Insulin for the Prevention of Delirium in ICU Patients Undergoing Elective Cardiac Surgery: a Randomized, Double-blind, Placebo-controlled Pilot Trial (INSPIRE)

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

Inclusion Criteria:

1. Age ≥65 years
2. 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
3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
4. Informed consent from patient

Exclusion Criteria:

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