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Hormone Therapy
Intranasal Insulin for Delirium (PODS Trial)
Phase 1 & 2
Recruiting
Led By Frank Weinhold, Pharm.D., MS
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from admission to the pacu until discharge from pacu, up to 18 hours from admission to the pacu
Awards & highlights
PODS Trial Summary
This trial will test the effects of intranasal insulin in humans to see if it can also help those who experience post-operative delirium.
Who is the study for?
This trial is for patients aged 65 or older who are undergoing elective surgery with vapor anesthesia and show signs of post-operative delirium, as determined by a CAM evaluation. It's not for those with low blood sugar, severe dementia, certain hormonal disorders, renal impairment, or allergies to insulin.Check my eligibility
What is being tested?
The study tests if intranasal insulin can reverse symptoms of post-operative delirium. Patients showing these symptoms after surgery will receive the treatment. The idea comes from successful use in Alzheimer's and AIDS-related confusion.See study design
What are the potential side effects?
Intranasal insulin has been mostly safe in past studies but may cause mild nasal irritation similar to that caused by saline solution. No serious drops in blood sugar levels were reported previously.
PODS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
People over 65 years old who have surgery with vapor anesthesia and show signs of confusion after surgery are included.
PODS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from admission to the pacu until discharge from pacu, up to 18 hours from admission to the pacu
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from admission to the pacu until discharge from pacu, up to 18 hours from admission to the pacu
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of intranasal insulin in resolving post-operative delirium
Secondary outcome measures
Length of stay in the post-anesthesia care unit (PACU)
PODS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
The treatment group will receive 40 IU via four activations of an intranasal spray.
Group II: Placebo GroupPlacebo Group1 Intervention
The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
460 Previous Clinical Trials
169,086 Total Patients Enrolled
Frank Weinhold, Pharm.D., MSPrincipal InvestigatorUniversity of Kansas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar level is less than 3.9 mmol/L before starting the study.You have had serious memory problems, lack of oxygen to the brain, or nerve/muscle disorders in the past.You are planning to use certain medications that can affect your blood sugar levels during the first four hours of surgery.You have allergies to insulin or certain medical conditions, are pregnant, or have certain health issues.People over 65 years old who have surgery with vapor anesthesia and show signs of confusion after surgery are included.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Placebo Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants to join this research program?
"The information provided by clinicaltrials.gov indicates that this medical study is currently accepting applications, having been initially posted on February 25th 2021 and last edited on May 2nd 2022."
Answered by AI
How many individuals are permitted to participate in this investigation?
"Affirmative. Clinicaltrials.gov attests that this project, which was first introduced on February 25th 2021, is actively recruiting participants. The clinical trial seeks to enroll 30 individuals at 1 site of a medical research centre."
Answered by AI
Could you provide information on the research previously conducted with regard to Treatment Group?
"Currently, 71 clinical trials related to Treatment Group are underway with 13 of them in Phase 3. While Cincinnati, Ohio is home to the bulk of these studies, 247 sites across the world have initiated research for this therapy."
Answered by AI
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