Intranasal Insulin to Prevent Intensive Care Unit Delirium (INSPIRE)

Radboud University Medical Center

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Delirium - Postoperative

Treatments: Drug: Intranasal insulin-40U; Drug: Intranasal sodium chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT07532577

2025-524680-21-00

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Intranasal insulin

Experimental group

Description:

Intranasal insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.

Treatment:

Drug: Intranasal insulin-40U

Intranasal placebo (NaCl 0.9%)

Placebo Comparator group

Description:

Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day.

Treatment:

Drug: Intranasal sodium chloride 0.9%