Phase 2
Completed N=22
Cardiac Surgery Neuroprotection Study in Elders
Post-operative Cognitive Decline · Post-operative Delirium
Source: ClinicalTrials.gov NCT01561378 ↗
Enrolled (actual)
22
Serious AEs
—
Results posted
Oct 2020
Primary outcomePrimary: Change From Baseline Cognitive Function
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.
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 |
— | — |
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. Informational only — not medical advice.