Cardiac Surgery Neuroprotection Study in Elders
| Status: | Completed |
|---|---|
| Conditions: | Cognitive Studies, Hospital, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 2/7/2015 |
| Start Date: | August 2012 |
| End Date: | December 2013 |
| Contact: | S. Jean Hsieh, MD |
| Email: | shsieh@montefiore.org |
| Phone: | 718-920-8319 |
Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients
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.
prevent post-operative cognitive decline and post-operative delirium in an elderly cardiac
surgery population.
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).
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).
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
We found this trial at
1
site
Click here to add this to my saved trials
