CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Aspart insulin +2 moredrug
Likely dose
Aspart insulin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01561378
NCT01561378Phase 2Completed

Intranasal Insulin for Neuroprotection in Elderly Cardiac Surgery Patients

Albert Einstein College of Medicine·interventional·Posted Mar 23, 2012·Updated Nov 10, 2021

In Brief

A Phase 2 clinical trial evaluating Aspart insulin, Normal saline, and 1 other intervention for Post-operative Cognitive Decline and Post-operative Delirium. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2012
Enrollment StartAug 1, 2012
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.3 years ago

Interventions

Aspart insulindrug

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)

Normal salinedrug

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)

Intranasal mucosal atomizer devicedevice

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.