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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal insulin | Experimental | Intranasal 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. |
|
| Intranasal placebo (NaCl 0.9%) | Placebo Comparator | Intranasal placebo (sodium chloride 0.9%) administered twice daily. Each administration consists of two sprays of 0.1 ml in alternating nostrils, totalling to 0.4 mL per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal insulin-40U | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: rate of recruitment | Proportion of eligible patients who are enrolled and randomized during the recruitment period. | From start of study to end of study, with a maximum of 12 months |
| Feasibility: protocol adherence | Number of administered doses divided by number of planned doses | From start of treatment up to a maximum of 5 days |
| Feasibility: participant retention and follow-up completeness | Proportion of randomized participants completing in-hospital data collection and 30-day follow-up (TICS-m). | From start of study to end of study, with a maximum of 12 months |
| Tolerability | - 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. | From start of treatment up to a maximum of 5 days |
| Exploratory efficacy | Delirium severity as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98) | From start of treatment up to a maximum of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium incidence | Defined as >= 1 positive delirium assessment(s) | From start of treatment up to a maximum of 7 days |
| Delirium severity | Numeric, as assessed with the Delirium Rating Scale-Revised-98 (DRS-R-98) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rens Kooken, MD | Contact | +3124361673 | rens.kooken@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Gelderland | 6525GA | Netherlands |
Upon reasonable request
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Randomized, double-blind, placebo-controlled pilot trial
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| Intranasal sodium chloride 0.9% | Drug | 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. |
|
| From start of treatment up to a maximum of 7 days |
| Delirium duration | Defined as number of days with positive delirium assessment | From start of treatment up to a maximum of 7 days |
| Delirium and coma-free days | Defined as the number of days without delirium or coma | From start of treatment up to a maximum of 7 days |
| Exposure to antipsychotics, sedatives and benzodiazepines | Defined as the number of patients receiving antipsychotics, sedatives, or benzodiazepines | From start of treatment up to a maximum of 7 days |
| Length of ICU stay | Defined as days spent in the ICU | From ICU admission to ICU discharge, assessed up to 6 months |
| Length of hospital stay | Defined as days spent in the hospital | From hospital admission to discharge, assessed up to 6 months |
| Change in cognitive function | Assessed with the modified Telephone Interview for Cognitive Status (TICS-m) at baseline (before hospital admission) and 30 days after surgery | From informed consent to 30 days post-surgery |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |