The effect of Intranasal insulin compared to usual care for the prevention of delirium in critically ill patients by day 14 or hospital discharge.

Intranasal insulin vs usual care for the prevention of delirium in critically ill patients aged 65 years and over at day 14 or hospital discharge; A multicentre randomised controlled trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626000716369

Enrollment

120

Registered

2026-06-16

Start date

2026-09-01

Completion date

2027-09-01

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Delirium is a medical condition characterised by abnormal functioning of the brain. Symptoms include confusion, poor attention, sleep disturbances, and agitation. Delirium commonly develops in hospitalised patients, particularly those who are elderly or indigenous. Patients with delirium are more likely to develop dementia, require care in a nursing home or even die. Intranasal insulin is an emerging novel therapy which has been successfully used to reduce the occurrence of delirium in post operative surgical patients. Intranasal insulin produces minimal systematic effect and has been shown not to impact blood glucose levels. It has been previously studied and shown to positively impact delirium duration in older geriatric in-hospital patients. There is currently a trial at the Prince of Wales hospital examining the effect on occurrence of delirium in orthogeriatric population. This study will investigate whether twice daily intranasal insulin reduces the occurrence of delirium in older critically ill patients in intensive care, a group that is known to be at high risk of delirium.

Interventions

30 IU of short acting insulin (insulin aspart) given intranasally twice a day (morning 8 am and Evening 6 pm) by bedside nurse or study staff for a maximum of 5 days while monitored in an Intensive Care Unit. There will be an accountability log for administration verified and signed by administering staff

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients must have ALL of the following for inclusion: 1. Equal or greater than 65 years old 2. Delirium free 3. Expected to be in ICU = 48 hours

Exclusion criteria

1. if their survival expectation is less than 7 days, 2. are allergic to insulin, 3. have structural abnormality that precludes the use of intranasal drug delivery, 4. are unable to participate in delirium assessment using CAM-ICU or 4-AT, 5. have a neurological disease with reduced level of consciousness assessed by Glasgow Coma Scale (GCS) of < 13. 6. Diabetic patients receiving insulin or hypoglycaemic agents 7. have fulminant liver failure, 8. on multiple antipsychotic medications, 9. Admitted with an overdose 10. judged to be unsuitable by treating clinician.

Outcome results