None listed
Conditions
Brief summary
Delirium is a transient and fluctuating cause of cerebral dysfunction and manifests with a wide range of cognitive and behavioural abnormalities. Delirium is associated with both increased morbidity and mortality and is a medical emergency. The sequelae of delirium are multiple and significant and extend well beyond the acute hospital stay. Delirium is associated with higher rates of death, medical complications, longer hospital stays, functional and cognitive decline and admission to residential aged care facilities. There are no registered pharmacological agents for the prevention or management of delirium. Pharmacological management is currently focused on symptomatic control with antipsychotics, as thus far, the cerebral abnormalities causing delirium have been poorly elucidated. We hypothesise that intranasal insulin, via its neuromodulatory effects, will reduce the rate of delirium leading to improved outcomes for patients and decreased costs of patient care in hospital. This RCT aims to evaluate the use of short-acting intranasal insulin in the prevention of delirium in patients undergoing orthopaedic surgery for femoral fractures. We will also assess the effect of intranasal insulin on duration and severity of delirium, acute and total hospital length of stay, complications, new residential aged care facility placement, cognitive decline, new onset of dementia, mortality, function, cost of care, quality of life (QoL) and emotional/mental impact on patients and caregivers.
Interventions
Nebulised intranasal insulin.
Drug: insulin aspart.
Dose: 30 international units (0.3mL) twice daily.
Device: Nasal drug delivery device (Teleflex MAD NasalTM Intranasal Mucosal Atomization Device).
Administration: Administration to a nostril twice daily (morning and evening) assisted by registered nurse.
Duration: Commence treatment on enrolment until day 3 post-surgery.
Monitoring adherence: Ward nurses will undergo training in preparation for the trial to ensure adherence to the trial proto
Nebulised intranasal insulin. Drug: insulin aspart. Dose: 30 international units (0.3mL) twice daily. Device: Nasal drug delivery device (Teleflex MAD NasalTM Intranasal Mucosal Atomization Device). Administration: Administration to a nostril twice daily (morning and evening) assisted by registered nurse. Duration: Commence treatment on enrolment until day 3 post-surgery. Monitoring adherence: Ward nurses will undergo training in preparation for the trial to ensure adherence to the trial protocol as well as consistent drug administration and documentation. Missed doses and tolerability will be documented by the nurses on electronic medical records and this will be reviewed by the study team.
Sponsors
Prof Gideon A Caplan, The Prince of Wales Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 75 years or older, or aged 65-74 years with pre-existing cognitive impairment and/or frailty (clinical frailty scale (CFS) >4). Undergoing orthopaedic surgery for femoral fractures (neck of femur, femoral shaft, distal femur and periprosthetic fractures of the femur). Receiving inpatient care at the Prince of Wales Hospital. Informed consent obtained.
Exclusion criteria
Prevalent delirium on admission to hospital diagnosed by a geriatrician or advanced trainee in geriatric medicine using the DSM-V criteria. Expected prognosis is less than 7 days lifespan assessed by admitting medical consultant opinion. Allergy to insulin formulation. A structural abnormality precluding the use of nasal drug delivery device. Unable to participate in cognitive testing and unable to establish whether the participant is at their neurocognitive baseline (i.e. at baseline cognition and function if pre-existing cognitive impairment) according to available sources of evidence (e.g. corroborative history from carer in addition to staff assessment on patient’s interaction, level of consciousness and fluctuations). Participant objects to treatment.
Outcome results
None listed