Delirium
Conditions
Brief summary
1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98)
Detailed description
Delirium incidence, dichotomous, defined as >= 1 positive delirium assessment(s), Delirium duration, defined as number of days with positive delirium assessment, Delirium and coma-free days, defined as number of days without delirium or coma, Antipsychotic, sedative and benzodiazepine exposure, defined as number of patients receiving antipsychotics, sedatives, or benzodiazepines., Length of ICU and hospital stay, defined as days spent in ICU and hospital, Change in cognitive function, assessed with the modified Telephone Interview for Cognitive Status (TICS m) at baseline (2 weeks prior to hospital admission) and 30 days after surgery
Interventions
DRUGInsulatard 100 international units/ml suspension for injection in vial.
Sponsors
Radboud universitair medisch centrum Stichting
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Feasibility, 2) tolerability and 3) exploratory efficacy, defined as: 1) Recruitment rate, protocol adherence (number of administered doses divided by number of planned doses), participant retention, follow-up completeness and effectiveness of blinding; 2) Local nasal adverse events (e.g., irritation, epistaxis) and incidence of hypoglycaemia, defined as the number of local nasal adverse events and hypoglycaemia events; 3) Delirium severity (DRS-R-98) | — |
Secondary
| Measure | Time frame |
|---|---|
| Delirium incidence, dichotomous, defined as >= 1 positive delirium assessment(s), Delirium duration, defined as number of days with positive delirium assessment, Delirium and coma-free days, defined as number of days without delirium or coma, Antipsychotic, sedative and benzodiazepine exposure, defined as number of patients receiving antipsychotics, sedatives, or benzodiazepines., Length of ICU and hospital stay, defined as days spent in ICU and hospital, Change in cognitive function, assessed with the modified Telephone Interview for Cognitive Status (TICS m) at baseline (2 weeks prior to hospital admission) and 30 days after surgery | — |
Outcome results
None listed