Post Operative Delirium Study (PODS)
Primary Purpose
Delirium
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring Insulin
Eligibility Criteria
Inclusion Criteria:
- All patients (>65 years of age) undergoing elective surgery using vapor anesthesia displaying post-operative delirium as defined by a CAM evaluation within time to PACU discharge post-surgery are eligible.
- Those patients 65 and older undergoing surgery using vapor anesthesia, who are consented but do not exhibit delirium and are not part of the study are still considered recruited subjects, but are not in the active study.
Exclusion Criteria:
- Patients with a history of severe dementia, anoxic brain injury, or neuromuscular disorders
- Non-English-speaking patients
- Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery
- thiazolidinediones
- hormones which may affect plasma glucose or insulin
- contraceptive, diphenylhydantoin
- patients with allergy to insulin
- acromegaly
- Cushing's syndrome
- hyperthyroidism and pheochromocytoma
- renal impairment
- pregnant and lactating women
- base line blood glucose < 3.9 mmol/L
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment Group
Placebo Group
Arm Description
The treatment group will receive 40 IU via four activations of an intranasal spray.
The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).
Outcomes
Primary Outcome Measures
Efficacy of intranasal insulin in resolving post-operative delirium
Measured by administering the Confusion Assessment Method (CAM) tool
Efficacy of intranasal insulin in resolving post-operative delirium
Measured by administering the Confusion Assessment Method tool
Efficacy of intranasal insulin in resolving post-operative delirium
Measured by administering the Confusion Assessment Method tool
Efficacy of intranasal insulin in resolving post-operative delirium
Measured by administering the Confusion Assessment Method tool
Secondary Outcome Measures
Length of stay in the post-anesthesia care unit (PACU)
Full Information
NCT ID
NCT04635774
First Posted
November 6, 2020
Last Updated
May 15, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04635774
Brief Title
Post Operative Delirium Study
Acronym
PODS
Official Title
Intranasal Insulin and Neurocognitive Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Post-operative delirium happens when patients wake up from anesthesia. Patients experiencing post-operative delirium are very confused, not being able to think or function "normally". These patients are hard to take care of and they tend to have more dementia as they age compared to patients who don't experience post-operative delirium. Intranasal insulin has been shown to reverse confusion associated with Alzheimer's disease (humans) and AIDS (mice).
Intranasal insulin has been safely administered to 1092 patients in 38 different studies. There were no cases of clinically low blood sugar and a few cases of mild nasal irritation that happened also with salt water when the subjects received multiple intranasal doses.
No one has tried to reverse post-operative delirium with intranasal insulin. The delirium associated with Alzheimer's Disease and AIDS have very similar symptoms and what happens in the brain is very similar also.
The investigators intent is to administer intranasal insulin to patients exhibiting post-operative delirium in order to reverse the symptoms because the investigators think that the three disease states are closely related and intranasal insulin has had some success in reversing the delirium in the other two disease states.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study is double-blind, randomized, placebo controlled. Neither the physician, patient, nor investigator will be aware of which patient is receiving insulin and which is receiving placebo. The treatment group will receive 40 IU via four activations of an intranasal spray. The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).
Both groups of patients receiving the insulin or placebo as intervention will be assessed with the CAM assessment at 10 min, 30min, and 60 min, and 6hr.
Masking
ParticipantCare ProviderInvestigator
Masking Description
The investigational pharmacist will use randomization software to randomize numbers 1-30. Each number will be randomized to either active drug (regular insulin) or placebo (normal saline).The investigational pharmacist will have the randomization table should un-blinding be required.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
The treatment group will receive 40 IU via four activations of an intranasal spray.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
40 IU via four activations of an intranasal spray
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Four activations of an intranasal spray containing placebo (normal saline).
Primary Outcome Measure Information:
Title
Efficacy of intranasal insulin in resolving post-operative delirium
Description
Measured by administering the Confusion Assessment Method (CAM) tool
Time Frame
10 min post diagnosis
Title
Efficacy of intranasal insulin in resolving post-operative delirium
Description
Measured by administering the Confusion Assessment Method tool
Time Frame
30 min post diagnosis
Title
Efficacy of intranasal insulin in resolving post-operative delirium
Description
Measured by administering the Confusion Assessment Method tool
Time Frame
60 min post diagnosis
Title
Efficacy of intranasal insulin in resolving post-operative delirium
Description
Measured by administering the Confusion Assessment Method tool
Time Frame
6 hours post diagnosis
Secondary Outcome Measure Information:
Title
Length of stay in the post-anesthesia care unit (PACU)
Time Frame
Time from admission to the PACU until discharge from PACU, up to 18 hours from admission to the PACU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients (>65 years of age) undergoing elective surgery using vapor anesthesia displaying post-operative delirium as defined by a CAM evaluation within time to PACU discharge post-surgery are eligible.
Those patients 65 and older undergoing surgery using vapor anesthesia, who are consented but do not exhibit delirium and are not part of the study are still considered recruited subjects, but are not in the active study.
Exclusion Criteria:
Patients with a history of severe dementia, anoxic brain injury, or neuromuscular disorders
Non-English-speaking patients
Planned use of drugs that effect plasma glucose concentration during the first four hours of surgery
thiazolidinediones
hormones which may affect plasma glucose or insulin
contraceptive, diphenylhydantoin
patients with allergy to insulin
acromegaly
Cushing's syndrome
hyperthyroidism and pheochromocytoma
renal impairment
pregnant and lactating women
base line blood glucose < 3.9 mmol/L
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Ballew, DC, MS
Phone
9139457420
Email
aballew@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Clark, MPA
Phone
913-945-5763
Email
mclark16@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Weinhold, Pharm.D., MS
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Weinhold, PharmD
Phone
913-588-9900
Email
weinhold@ku.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Post Operative Delirium Study
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