Intranasal insulin for the prevention of delirium in ICU patients undergoing elective cardiac surgery: a randomized, double blind, placebo controlled pilot trial (INSPIRE)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Radboud universitair medisch centrum Stichting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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)
Overview
Brief Summary
This study aims to assess the feasibility, tolerability, and preliminary exploratory efficacy of intranasal insulin to prevent delirium in ICU patients aged ≥65 years after complex elective cardiac surgery with cardiopulmonary bypass.
Eligibility Criteria
- Ages
- 65 years to 65+ years (65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥65 years
- •Planned surgical admission to the ICU of the Radboudumc following complex cardiac surgery with CPB. Complex surgery is defined as: combined procedures (e.g., multi-vessel CABG or single CABG + valve replace-ment/repair); or aortic surgery (ascending aorta, arch, or root) or repair of aortic dissection; or expected CPB duration ≥ 90 minutes, as estimated preoperatively
- •Able to receive intranasal spray (no obstructive nasal pathology precluding administration)
- •Informed consent from patient
Exclusion Criteria
- •Delirium or dementia present at baseline
- •Single-vessel CABG, single valve replacement/repair or off-pump cardiac surgery
- •Known allergy/hypersensitivity to insulin or formulation excipients
- •Contra-indication for nasal administration (severe nasal pathology, recent nasal/sinus sur-gery, active epistaxis, active rhinitis, obstruction of either one or both nostrils)
Outcomes
Primary Outcomes
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)
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 Outcomes
- 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
Investigators
Mark van den Boogaard
Scientific
Radboud universitair medisch centrum Stichting