Intranasal insulin for treatment of delirium in older hospitalised patients: study protocol for a randomised controlled trial.

Nitchingham, A; Milne, A; Toson, B; Tuch, B; Agar, M; Close, J; Caplan, G

Intranasal insulin for treatment of delirium in older hospitalised patients: study protocol for a randomised controlled trial.

Nitchingham, A Milne, A Toson, B Tuch, B Agar, M

Close, J Caplan, G

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Publisher:: BMJ
Publication Type:: Journal Article
Citation:: BMJ open, 2021, 11, (10), pp. e050765
Issue Date:: 2021-10-19

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Field	Value	Language
dc.contributor.author	Nitchingham, A
dc.contributor.author	Milne, A
dc.contributor.author	Toson, B
dc.contributor.author	Tuch, B
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	Close, J
dc.contributor.author	Caplan, G
dc.date.accessioned	2022-01-04T01:08:28Z
dc.date.available	2022-01-04T01:08:28Z
dc.date.issued	2021-10-19
dc.identifier.citation	BMJ open, 2021, 11, (10), pp. e050765
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/152634
dc.description.abstract	<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>ACTRN12618000318280.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ
dc.relation.ispartof	BMJ open
dc.relation.isbasedon	10.1136/bmjopen-2021-050765
dc.rights	© Author(s) (or their employer(s)) 2021. Re- use permitted under CC BY- NC. No commercial re- use. See rights and permissions. Published by BMJ
dc.rights	info:eu-repo/semantics/restrictedAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.mesh	Humans
dc.subject.mesh	Delirium
dc.subject.mesh	Insulin
dc.subject.mesh	Aftercare
dc.subject.mesh	Patient Discharge
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Aged
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Aftercare
dc.subject.mesh	Aged
dc.subject.mesh	Delirium
dc.subject.mesh	Humans
dc.subject.mesh	Insulin
dc.subject.mesh	Patient Discharge
dc.subject.mesh	Prospective Studies
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.title	Intranasal insulin for treatment of delirium in older hospitalised patients: study protocol for a randomised controlled trial.
dc.type	Journal Article
utslib.citation.volume	11
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	recently_added	*
dc.date.updated	2022-01-04T01:08:25Z
pubs.issue	10
pubs.publication-status	Published
pubs.volume	11
utslib.citation.issue	10

Abstract:

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.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/152634