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Intranasal insulin for treatment of delirium in older hospitalised patients: study protocol for a randomised
Anita Nitchingham1,2, Andrew Milne3, Barbara Toson4
1Department of Geriatric Medicine, Prince of Wales Hospital, Sydney, New South Wales, Australia a.nitchingham@unsw.edu.au.
Introduction:
Delirium is one of the most common conditions diagnosed in hospitalised older people and is associated with numerous adverse outcomes, yet there are no proven pharmacological treatments. Recent research has identified cerebral glucose hypometabolism as a pathophysiological mechanism offering a therapeutic target in delirium. Insulin, delivered via the intranasal route, acts directly on the central nervous system and has been shown to enhance cerebral metabolism and improve cognition in patients with mild cognitive impairment and dementia. This trial will determine whether intranasal insulin can reduce the duration of delirium in older hospitalised patients.
Methods And Analysis:
This is a prospective randomised, placebo-controlled, double-blind study with 6 months follow-up. One hundred patients aged 65 years or older presenting to hospital with delirium admitted under geriatric medicine will be recruited. Participants will be randomised to intranasal insulin detemir or placebo administered twice daily until delirium resolves, defined as Confusion Assessment Method (CAM) negative for 2 days, or discharge from hospital. The primary outcome measure will be duration of delirium using the CAM. Secondary outcome measures will include length of hospital stay, severity of delirium, adherence to treatment, hospital complications, new admission to nursing home, mortality, use of antipsychotic medications during hospital stay and cognitive and physical function at 6 months postdischarge.
Ethics And Dissemination:
This trial has been approved by the South Eastern Sydney Human Research and Ethics Committee. Dissemination plans include submission to a peer-reviewed journal for publication and presentation at scientific conferences.
Trial Registration Number:
ACTRN12618000318280.
Insights
This study investigates intranasal insulin for treating delirium in older adults. Researchers aim to determine if this treatment can shorten delirium duration and improve patient outcomes in hospital settings.
Area of Science:
- Geriatric Medicine
- Neuroscience
- Pharmacology
Background:
- Delirium is a common, adverse condition in hospitalized older adults with no proven pharmacological treatments.
- Cerebral glucose hypometabolism is a potential therapeutic target for delirium.
- Intranasal insulin enhances cerebral metabolism and cognition, offering a potential treatment avenue.
Purpose of the Study:
- To evaluate the efficacy of intranasal insulin in reducing the duration of delirium in hospitalized older patients.
- To assess the impact of intranasal insulin on various secondary outcomes, including hospital stay and patient function.
Main Methods:
- A prospective, randomized, placebo-controlled, double-blind study with 6 months follow-up.
- Recruitment of 100 patients aged 65+ presenting with delirium.
- Randomization to intranasal insulin detemir or placebo until delirium resolution or hospital discharge, with the Confusion Assessment Method (CAM) as the primary outcome measure.
Main Results:
- Primary outcome: duration of delirium measured by CAM.
- Secondary outcomes: length of hospital stay, delirium severity, adherence, complications, nursing home admission, mortality, antipsychotic use, and 6-month cognitive/physical function.
Conclusions:
- The trial will provide crucial data on the effectiveness of intranasal insulin for delirium management in older adults.
- Findings may lead to a novel pharmacological treatment for this common and debilitating condition.
