Cardiac Surgery Neuroprotection Study in Elders

NCT01561378 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2010-538R03AG040673
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Cognitive Decline; Post-operative Delirium

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Cognitive Function

  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.

  6-weeks

Secondary Outcomes (7)

• Delirium and Coma Free Days

  7 days

• Association Between Post-operative Delirium and Post-operative Cognitive Decline

  7 days, 6 weeks

• Hypoglycemia

  14 days

• Nasal Irritation

  14 days

• Survival

  30-day, 90-day

Study Arms (2)

Insulin

EXPERIMENTAL

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; Device: Intranasal mucosal atomizer device

Normal saline

PLACEBO COMPARATOR

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; Device: Intranasal mucosal atomizer device

Interventions

Aspart insulin 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)

Also known as: NovoLog

Insulin

Normal saline 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)

Also known as: 0.9% sodium chloride solution

Normal saline

Intranasal mucosal atomizer device 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.

Also known as: mucosal atomizer device, MAD

Insulin; Normal saline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• elderly patients (\>=65 years old)
• undergoing elective coronary artery bypass graft and/or valve surgery requiring cardiopulmonary bypass
• English or Spanish-speaking

You may not qualify if:

• severe dementia, neurodegenerative, or psychiatric disease that prevents patient from living independently at baseline
• emergent surgery
• inability to perform cognitive testing (i.e. difficulty hearing or inability to speak)
• contraindications to intranasal administration of medication

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Albert Einstein College of Medicine - Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Insulin Aspart; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The PI has left the institution. Efforts were made to contact the PI/study team members on several occasions, but were unsuccessful. Besides the amount of patients accrued to each arm/group, no study or adverse event data are available.

Results Point of Contact

• Title: Daniel Ceusters
• Organization: Montefiore Medical Center

dceuster@montefiore.org

718-920-2956

Study Officials

• Shi-jun Jean Hsieh, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 23, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 10, 2021
• Results First Posted: October 22, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)