Trial record 1 of 1 for:    Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients
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Cardiac Surgery Neuroprotection Study in Elders (CNS-Elders)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
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 23, 2013
Last verified: January 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
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)
Other Name: Placebo

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
Genders Eligible for Study:   Both
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

Contacts
Contact: S. Jean Hsieh, MD 718-920-8319 shsieh@montefiore.org
Contact: Michelle Ng Gong, MD, MS 718-920-2956 mgong@montefiore.org

Locations
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    shsieh@montefiore.org   
Contact: Michelle Ng Gong, MD, MS    718-920-2956    mgong@montefiore.org   
Principal Investigator: S. Jean Hsieh, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Shi-jun Jean Hsieh, MD Albert Einstein College of Medicine - Montefiore Medical Center
  More Information

No publications provided

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
Study First Received: March 20, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014