NCT07532577

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)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Delirium - Postoperative

Interventions

Type	Name	Description
DRUG	Intranasal insulin-40U	Intranasal isophane 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.
DRUG	Intranasal sodium chloride 0.9%	Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-07-15
• Completion: 2026-08-15
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: Netherlands