CompletedPhase 2ACTRN12618000318280

Intranasal insulin for treatment of delirium.

A phase 2 single site, double blind randomised placebo controlled trial of intranasal insulin for the management of delirium in patients over 65 years old.


Sponsor

A/Prof Gideon A Caplan

Enrollment

100 participants

Start Date

Mar 12, 2018

Study Type

Interventional

Conditions

Summary

Delirium is a common medical condition characterised by sudden and fluctuating disturbances in thinking, attention and consciousness. Affecting up to one in four hospitalised older people, delirium is considered a medical emergency because it causes premature death, admission to nursing home, dementia, longer stays in hospital and loss of independence. Currently, there are no licenced treatments for people with delirium for use in the Emergency Department or on hospital wards. The most popular off-licence treatment for delirium, antipsychotics, was recently shown to worsen symptoms and increase death. The need to discover safe treatments is urgent. Recent research has identified significant changes in brain glucose (sugar) metabolism during an episode of delirium. Insulin receptors are widely expressed in the brain and insulin delivered via nasal spray (intranasal insulin) has been shown to increase glucose uptake in the brain. Intranasal insulin has been tested in older people and was found to be safe and may be associated with an improved cognitive function. The effect of intranasal insulin in delirium has previously not been evaluated. We will study intranasal insulin to treat delirium in people coming to the Emergency Department at Prince of Wales Hospital. We will conduct a randomised double blind placebo controlled trial of 100 patients and scientifically evaluate the effect of intranasal insulin compared to salt water (saline). Neither the Doctor nor the study participant knows which treatment the participant is receiving. Patients will be reviewed daily by an Aged Care Specialist while they have delirium and be followed up at six months. The primary objective is to evaluate if intranasal insulin reduces the duration of delirium in hospitalised older adults. Secondary objectives will assess if intranasal insulin decreases the length of hospital stay, reduces the percentage of people discharged to residential care, reduces death during admission and at six months, reduces delirium severity and preserves cognitive status six months post-delirium.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Inclusion Criteria5

  • Prevalent delirium (presenting to hospital with delirium), regardless of cause diagnosed using the confusion assessment method.
  • Receiving inpatient care at the Prince of Wales Hospital.
  • Age >65 years.
  • Enrolment within 48hours of admission.
  • Informed consent obtained.

Exclusion Criteria7

  • Haemodynamic instability requiring inotropic support.
  • Expected prognosis is less than 7 days lifespan by admitting medical consultant opinion.
  • Allergy to insulin detemir formulation.
  • Structural abnormality precluding the use of a nasal drug delivery device.
  • Consent unable to be obtained.
  • Previous enrolment in the trial.
  • Proven or suspected COVID-19

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Interventions

Nebulised intranasal insulin. Drug: insulin detemir. Dose: 20 international units twice daily. Device: Nasal drug delivery device (ViaNase delivery device, Kurve Technology, Bothell, Washington).

Nebulised intranasal insulin. Drug: insulin detemir. Dose: 20 international units twice daily. Device: Nasal drug delivery device (ViaNase delivery device, Kurve Technology, Bothell, Washington). Administration: 20 seconds both nostrils twice daily (8am and 8pm) assisted by registered nurse. Duration: Commence within 48 hours of presentation to hospital. Stop when delirium resolved (48hours delirium free) or discharged from hospital. Monitoring adherence: nurses will document on electronic medical record whether medication was able to be administered. Study team will audit successful doses administered for each patient.


Locations(1)

Prince of Wales Hospital - Randwick

NSW, Australia

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