Cardiac Surgery Neuroprotection Study in Elders

NCT ID: NCT01561378

Last Updated: 2021-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-10-31

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).

Conditions

Post-operative Cognitive Decline; Post-operative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Insulin

Aspart Insulin 40 IU intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first

Group Type: EXPERIMENTAL

Aspart insulin

Intervention Type: DRUG

40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal 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)

Intranasal mucosal atomizer device

Intervention Type: DEVICE

Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity.

Normal saline

Normal saline (0.9% sodium chloride solution) intranasal spray via intranasal mucosal atomizer device, four times a day for 7 days or until hospital discharge, whichever occurs first

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

200 microliters of normal saline will be administered per nostril using an intranasal 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)

Intranasal mucosal atomizer device

Intervention Type: DEVICE

Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity.

Interventions

Aspart insulin

40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal 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)

Intervention Type: DRUG

Normal saline

200 microliters of normal saline will be administered per nostril using an intranasal 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)

Intervention Type: DRUG

Intranasal mucosal atomizer device

Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity.

Intervention Type: DEVICE

Other Intervention Names

NovoLog; 0.9% sodium chloride solution; mucosal atomizer device, MAD

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shi-jun Jean Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine Montefiore Medical Center

Locations

Albert Einstein College of Medicine - Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

R03AG040673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-538

Identifier Type: -

Identifier Source: org_study_id