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

March 20, 2012
January 23, 2013
August 2012
September 2013   (final data collection date for primary outcome measure)
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.
  • Composite cognitive Z-score [ 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), 7 days after surgery or before hospital discharge (whichever occurs first), and 6 weeks after discharge.
  • Delirium/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)
Complete list of historical versions of study NCT01561378 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Delirium duration [ Time Frame: 7 days ] [ 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 ]
Not Provided
Not Provided
 
Cardiac Surgery Neuroprotection Study in Elders
Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Post-operative Cognitive Decline
  • Post-operative Delirium
  • 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
  • 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
  • Experimental: Insulin
    Aspart Insulin 40 IU intranasal spray, four times a day for 7 days or until hospital discharge, whichever occurs first
    Intervention: Drug: Aspart insulin
  • Placebo Comparator: Placebo
    Saline intranasal spray, four times a day for 7 days or until hospital discharge, whichever occurs first
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: S. Jean Hsieh, MD 718-920-8319 shsieh@montefiore.org
Contact: Michelle Ng Gong, MD, MS 718-920-2956 mgong@montefiore.org
United States
 
NCT01561378
2010-538, R03AG040673
Yes
Shi-jun Jean Hsieh, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
National Institute on Aging (NIA)
Principal Investigator: Shi-jun Jean Hsieh, MD Albert Einstein College of Medicine - Montefiore Medical Center
Albert Einstein College of Medicine of Yeshiva University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP