Cardiac Surgery Neuroprotection Study in Elders

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Post-operative Cognitive DeclinePost-operative Delirium
Interventions
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)

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)

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.

Trial Locations (1)

10467

Albert Einstein College of Medicine - Montefiore Medical Center, The Bronx

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Albert Einstein College of Medicine

OTHER

NCT01561378 - Cardiac Surgery Neuroprotection Study in Elders | Biotech Hunter | Biotech Hunter