Clinical trial NCT01561378: Cardiac Surgery Neuroprotection Study in Elders
Official title: Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-operative Cognitive Decline
Post-operative Delirium
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2012-03-23
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

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

Primary outcomes:
measure: Change From Baseline Cognitive Function
timeFrame: 6-weeks
Secondary outcomes:
measure: Delirium and Coma Free Days
timeFrame: 7 days
measure: Association Between Post-operative Delirium and Post-operative Cognitive Decline
timeFrame: 7 days, 6 weeks
measure: Hypoglycemia
timeFrame: 14 days
measure: Nasal Irritation
timeFrame: 14 days
measure: Survival
timeFrame: 30-day, 90-day
measure: ICU Length of Stay
timeFrame: 1 to 90 days
measure: Hospital Length of Stay
timeFrame: 1 to 90 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine - Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine Montefiore Medical Center
name: Shi-jun Jean Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: