Brief 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.
Brief Title
Cardiac Surgery Neuroprotection Study in Elders
Detailed Description
Nearly half of all intensive care unit (ICU) admissions consist of adults \> 65 years old, an age group that is at high risk for developing cognitive decline and delirium in the ICU. Over 50% and 70% of critically ill cardiac surgery patients develop post-operative delirium (POD) and post-operative cognitive decline (POCD), respectively. These two forms of acute cognitive dysfunction are associated with increased mortality and poor functional recovery. While distinct conditions, POD has been associated with the subsequent development of POCD, suggesting a mechanistic link.
No proven pharmacologic treatments targeting the prevention of both POD and POCD in elderly patients exist to date. Recent data suggest that insulin administered into the central nervous system via intranasal delivery improves cognitive function in elderly patients with Alzheimer's disease and mild cognitive impairment. However, its utility in preventing POD and POCD in elderly critically ill patients has not been investigated.
The hypothesis of this study is that intranasal insulin can prevent POD and POCD in elderly critically ill patients admitted to the intensive care unit after undergoing cardiac surgery. To test this hypothesis, this randomized, placebo-controlled, double-blinded Phase II study will enroll 60 patients \>= 65 years old undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass, and will treat them with either 40 IU of aspart insulin or placebo intranasally before surgery and then four times a day for 7 days or until hospital discharge (whichever occurs first).
No proven pharmacologic treatments targeting the prevention of both POD and POCD in elderly patients exist to date. Recent data suggest that insulin administered into the central nervous system via intranasal delivery improves cognitive function in elderly patients with Alzheimer's disease and mild cognitive impairment. However, its utility in preventing POD and POCD in elderly critically ill patients has not been investigated.
The hypothesis of this study is that intranasal insulin can prevent POD and POCD in elderly critically ill patients admitted to the intensive care unit after undergoing cardiac surgery. To test this hypothesis, this randomized, placebo-controlled, double-blinded Phase II study will enroll 60 patients \>= 65 years old undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass, and will treat them with either 40 IU of aspart insulin or placebo intranasally before surgery and then four times a day for 7 days or until hospital discharge (whichever occurs first).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Post-operative Cognitive Decline
Post-operative Delirium
Eligibility Criteria
Inclusion Criteria:
1. elderly patients (\>=65 years old)
2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
3. English or Spanish-speaking
Exclusion Criteria:
1. severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline
2. emergent surgery
3. inability to perform cognitive testing (i.e. difficulty hearing or inability to speak)
4. contraindications to intranasal administration of medication
1. elderly patients (\>=65 years old)
2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
3. English or Spanish-speaking
Exclusion Criteria:
1. severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline
2. emergent surgery
3. inability to perform cognitive testing (i.e. difficulty hearing or inability to speak)
4. contraindications to intranasal administration of medication
Inclusion Criteria
Inclusion Criteria:
1. elderly patients (\>=65 years old)
2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
3. English or Spanish-speaking
1. elderly patients (\>=65 years old)
2. undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
3. English or Spanish-speaking
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT01561378
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2010-538
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients
Primary Outcomes
Outcome Description
Assessed using a battery of cognitive tests which test the following four domains: 1) executive function, 2) verbal memory, 3) attention and concentration, 4) language. Cognitive testing will be performed at the following time points: baseline (1-2 weeks prior to surgery) and 6 weeks after discharge.
Outcome Measure
Change From Baseline Cognitive Function
Outcome Time Frame
6-weeks
Secondary Ids
Secondary Id
R03AG040673
Secondary Outcomes
Outcome Description
Assessed using the Richmond Agitation Sedation Scale (RASS) and Confusion Assessment Method-ICU (CAM-ICU)
Outcome Time Frame
7 days
Outcome Measure
Delirium and Coma Free Days
Outcome Time Frame
7 days, 6 weeks
Outcome Measure
Association Between Post-operative Delirium and Post-operative Cognitive Decline
Outcome Time Frame
14 days
Outcome Measure
Hypoglycemia
Outcome Time Frame
14 days
Outcome Measure
Nasal Irritation
Outcome Time Frame
30-day, 90-day
Outcome Measure
Survival
Outcome Time Frame
1 to 90 days
Outcome Measure
ICU Length of Stay
Outcome Time Frame
1 to 90 days
Outcome Measure
Hospital Length of Stay
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Shijun Hsieh
Investigator Email
shsieh@montefiore.org
Investigator Phone