Cardiac Surgery Neuroprotection Study in Elders (CNS-Elders)
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.
Post-operative Cognitive Decline
Drug: Aspart insulin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients|
- Change from baseline cognitive function [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]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.
- Delirium and Coma Free Days [ Time Frame: 7 days ] [ Designated as safety issue: No ]Assessed using the Richmond Agitation Sedation Scale (RASS) and Confusion Assessment Method-ICU (CAM-ICU)
- Association between post-operative delirium and post-operative cognitive decline [ Time Frame: 7 days, 6 weeks ] [ Designated as safety issue: No ]
- Hypoglycemia [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Nasal irritation [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: 30-day, 90-day ] [ Designated as safety issue: No ]
- ICU length of stay [ Time Frame: 1 to 90 days ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: 1 to 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Aspart Insulin 40 IU intranasal spray, four times a day for 7 days or until hospital discharge, whichever occurs first
Drug: Aspart insulin
40 IU of aspart insulin will be administered intranasally using a mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)
Other Name: NovoLog
Placebo Comparator: Placebo
Saline intranasal spray, four times a day for 7 days or until hospital discharge, whichever occurs first
200 microliters of normal saline will be administered per nostril using a mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)
Other Name: Placebo
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).
|Contact: S. Jean Hsieh, MDfirstname.lastname@example.org|
|Contact: Michelle Ng Gong, MD, MSemail@example.com|
|United States, New York|
|Albert Einstein College of Medicine - Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: S. Jean Hsieh, MD 718-920-8319 firstname.lastname@example.org|
|Contact: Michelle Ng Gong, MD, MS 718-920-2956 email@example.com|
|Principal Investigator: S. Jean Hsieh, MD|
|Principal Investigator:||Shi-jun Jean Hsieh, MD||Albert Einstein College of Medicine - Montefiore Medical Center|