Delirium - Postoperative
Conditions
Brief summary
This study aims to assess the feasibility, tolerability, and exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass
Interventions
Intranasal isophane insulin administered twice daily. Each administration consists of two sprays of 10 IU (0.1 ml) in alternating nostrils, totalling to 40 IU per day.
DRUGIntranasal sodium chloride 0.9%
Intranasal sodium chloride 0.9% administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4mL per day.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled pilot trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥65 years 2. Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex cardiac surgery is defined as all cardiac on-pump procedures except for isolated CABG 3. Able to receive intranasal spray (no obstructive nasal pathology precluding administration) 4. Informed consent from patient
Exclusion criteria
1. Delirium at hospital admission 2. Non-complex or off-pump cardiac surgery 3. Known allergy/hypersensitivity to insulin or formulation excipients 4. Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus surgery, active epistaxis, active rhinitis, obstruction of either one or both nostrils) 5. Participating in other investigational medication trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: rate of recruitment | From start of study to end of study, with a maximum of 12 months | Proportion of eligible patients who are enrolled and randomized during the recruitment period. |
| Feasibility: protocol adherence | From start of treatment up to a maximum of 5 days | Number of administered doses divided by number of planned doses |
| Feasibility: participant retention and follow-up completeness | From start of study to end of study, with a maximum of 12 months | Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m). |
| Tolerability | From start of treatment up to a maximum of 5 days | \- Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia (mild: glucose \<4.1 mmol/L, severe: \<2.2 mmol/L), defined as the number of local nasal adverse events and hypoglycaemia events. |
| Exploratory efficacy | From start of treatment up to a maximum of 7 days | Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delirium incidence | From start of treatment up to a maximum of 7 days | Defined as \>= 1 positive delirium assessment(s) |
| Delirium severity | From start of treatment up to a maximum of 7 days | Numeric, as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98) |
| Delirium duration | From start of treatment up to a maximum of 7 days | Defined as number of days with positive delirium assessment |
| Delirium and coma-free days | From start of treatment up to a maximum of 7 days | Defined as the number of days without delirium or coma |
| Exposure to antipsychotics, sedatives and benzodiazepines | From start of treatment up to a maximum of 7 days | Defined as the number of patients receiving antipsychotics, sedatives, or benzodiazepines |
| Length of ICU stay | From ICU admission to ICU discharge, assessed up to 6 months | Defined as days spent in the ICU |
| Length of hospital stay | From hospital admission to discharge, assessed up to 6 months | Defined as days spent in the hospital |
| Change in cognitive function | From informed consent to 30 days post-surgery | Assessed with the modified Telephone Interview for Cognitive Status (TICS-m) at baseline (before hospital admission) and 30 days after surgery |
Countries
Netherlands
Outcome results
None listed