Intranasal Insulin to Prevent Intensive Care Unit Delirium

NCT07532577 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-524680-21-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Feasibility: rate of recruitment

  Proportion of eligible patients who are enrolled and randomized during the recruitment period.

  From start of study to end of study, with a maximum of 12 months

• Feasibility: protocol adherence

  Number of administered doses divided by number of planned doses

  From start of treatment up to a maximum of 5 days

• Feasibility: participant retention and follow-up completeness

  Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m).

  From start of study to end of study, with a maximum of 12 months

• Tolerability

  \- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose \<4.1 mmol/L, severe: \<2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events.

  From start of treatment up to a maximum of 5 days

• Exploratory efficacy

  Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98)

  From start of treatment up to a maximum of 7 days

Secondary Outcomes (8)

• Delirium incidence

  From start of treatment up to a maximum of 7 days

• Delirium severity

  From start of treatment up to a maximum of 7 days

• Delirium duration

  From start of treatment up to a maximum of 7 days

• Delirium and coma-free days

  From start of treatment up to a maximum of 7 days

• Exposure to antipsychotics, sedatives and benzodiazepines

  From start of treatment up to a maximum of 7 days

Study Arms (2)

Intranasal insulin

EXPERIMENTAL

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.

Drug: Intranasal insulin-40U

Intranasal placebo (NaCl 0.9%)

PLACEBO COMPARATOR

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.

Drug: Intranasal sodium chloride 0.9%

Interventions

Intranasal insulin-40U DRUG

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.

Intranasal insulin

Intranasal sodium chloride 0.9% DRUG

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.

Intranasal placebo (NaCl 0.9%)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rens Kooken, MD

CONTACT

+3124361673; rens.kooken@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled pilot trial

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)