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Cardiac Surgery Neuroprotection Study in Elders (CNS-Elders)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Shi-jun Jean Hsieh, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01561378
First received: March 20, 2012
Last updated: January 13, 2015
Last verified: January 2015
  Purpose
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 Intervention Phase
Post-operative Cognitive Decline Post-operative Delirium Drug: Aspart insulin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shi-jun Jean Hsieh, Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • 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:
  • Delirium and Coma Free Days [ Time Frame: 7 days ]
    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 ]
  • Hypoglycemia [ Time Frame: 14 days ]
  • Nasal irritation [ Time Frame: 14 days ]
  • Survival [ Time Frame: 30-day, 90-day ]
  • ICU length of stay [ Time Frame: 1 to 90 days ]
  • Hospital length of stay [ Time Frame: 1 to 90 days ]

Enrollment: 22
Study Start Date: August 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin
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
Drug: Placebo
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)

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

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561378

Locations
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, Inc.
National Institute on Aging (NIA)
Investigators
Principal Investigator: Shi-jun Jean Hsieh, MD Albert Einstein College of Medicine - Montefiore Medical Center
  More Information

Responsible Party: Shi-jun Jean Hsieh, Assistant Professor, Department of Medicine, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01561378     History of Changes
Other Study ID Numbers: 2010-538
R03AG040673 ( U.S. NIH Grant/Contract )
Study First Received: March 20, 2012
Last Updated: January 13, 2015

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017