Phase 2
N=22
Cardiac Surgery Neuroprotection Study in Elders
Post-operative Cognitive Decline · Post-operative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT01561378 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Oct 2020
Primary outcome: Primary: Change From Baseline Cognitive Function
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aspart insulin (Drug); Normal saline (Drug); Intranasal mucosal atomizer device (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Cognitive Function |
— | — |
| SECONDARY Delirium and Coma Free Days |
— | — |
| SECONDARY Association Between Post-operative Delirium and Post-operative Cognitive Decline |
— | — |
| SECONDARY Hypoglycemia |
— | — |
| SECONDARY Nasal Irritation |
— | — |
| SECONDARY Survival |
— | — |
| SECONDARY ICU Length of Stay |
— | — |
| SECONDARY Hospital Length of Stay |
— | — |
Summary
The goal of this study is to determine the potential ability of intranasal insulin to prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac surgery population.
Eligibility Criteria
Inclusion Criteria
- elderly patients (>=65 years old)
- undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
- English or Spanish-speaking
Exclusion Criteria
- severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline
- emergent surgery
- inability to perform cognitive testing (i.e. difficulty hearing or inability to speak)
- contraindications to intranasal administration of medication
Data sourced from ClinicalTrials.gov (NCT01561378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.