Trial Outcomes & Findings for Cardiac Surgery Neuroprotection Study in Elders (NCT NCT01561378)
NCT ID: NCT01561378
Last Updated: 2021-11-10
Results Overview
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.
COMPLETED
PHASE2
22 participants
6-weeks
2021-11-10
Participant Flow
Participant milestones
| Measure |
Insulin
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
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)
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.
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Normal Saline
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
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)
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.
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Overall Study
STARTED
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11
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11
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Overall Study
COMPLETED
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11
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11
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Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cardiac Surgery Neuroprotection Study in Elders
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 6-weeksPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 daysPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Assessed using the Richmond Agitation Sedation Scale (RASS) and Confusion Assessment Method-ICU (CAM-ICU)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 days, 6 weeksPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30-day, 90-dayPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 to 90 daysPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 to 90 daysPopulation: The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Outcome measures
Outcome data not reported
Adverse Events
Insulin
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place