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Cardiac Surgery Neuroprotection Study in Elders (CNS-Elders)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01561378
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : October 22, 2020
Last Update Posted : November 10, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Post-operative Cognitive Decline Post-operative Delirium Drug: Aspart insulin Drug: Normal saline Device: Intranasal mucosal atomizer device Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients
Study Start Date : August 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: 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
Drug: 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)
Other Name: NovoLog

Device: 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.
Other Name: mucosal atomizer device, MAD

Placebo Comparator: 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
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)
Other Name: 0.9% sodium chloride solution

Device: 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.
Other Name: mucosal atomizer device, MAD




Primary Outcome Measures :
  1. Change From Baseline Cognitive Function [ Time Frame: 6-weeks ]
    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.


Secondary Outcome Measures :
  1. Delirium and Coma Free Days [ Time Frame: 7 days ]
    Assessed using the Richmond Agitation Sedation Scale (RASS) and Confusion Assessment Method-ICU (CAM-ICU)

  2. Association Between Post-operative Delirium and Post-operative Cognitive Decline [ Time Frame: 7 days, 6 weeks ]
  3. Hypoglycemia [ Time Frame: 14 days ]
  4. Nasal Irritation [ Time Frame: 14 days ]
  5. Survival [ Time Frame: 30-day, 90-day ]
  6. ICU Length of Stay [ Time Frame: 1 to 90 days ]
  7. Hospital Length of Stay [ Time Frame: 1 to 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561378


Locations
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United States, New York
Albert Einstein College of Medicine - Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Shi-jun Jean Hsieh, MD Albert Einstein College of Medicine - Montefiore Medical Center
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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01561378    
Other Study ID Numbers: 2010-538
R03AG040673 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2012    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs