PODS: Post Operative Delirium Study

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04635774

Collaborator

(none)

Enrollment

Location

Arms

34.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: Insulin Drug: Saline	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Triple (Participant, Care Provider, Investigator)

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.

Primary Purpose:

Treatment

Official Title:

Intranasal Insulin and Neurocognitive Function

Actual Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group The treatment group will receive 40 IU via four activations of an intranasal spray.	Drug: Insulin 40 IU via four activations of an intranasal spray
Placebo Comparator: Placebo Group The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).	Drug: Saline Four activations of an intranasal spray containing placebo (normal saline).

Arm

Intervention/Treatment

Active Comparator: Treatment Group

The treatment group will receive 40 IU via four activations of an intranasal spray.

Drug: Insulin

40 IU via four activations of an intranasal spray

Placebo Comparator: Placebo Group

The placebo group will receive four activations of an intranasal spray containing placebo (normal saline).

Drug: Saline

Four activations of an intranasal spray containing placebo (normal saline).

Outcome Measures

Primary Outcome Measures

Efficacy of intranasal insulin in resolving post-operative delirium [10 min post diagnosis]
Measured by administering the Confusion Assessment Method (CAM) tool
Efficacy of intranasal insulin in resolving post-operative delirium [30 min post diagnosis]
Measured by administering the Confusion Assessment Method tool
Efficacy of intranasal insulin in resolving post-operative delirium [60 min post diagnosis]
Measured by administering the Confusion Assessment Method tool
Efficacy of intranasal insulin in resolving post-operative delirium [6 hours post diagnosis]
Measured by administering the Confusion Assessment Method tool

Secondary Outcome Measures

Length of stay in the post-anesthesia care unit (PACU) [Time from admission to the PACU until discharge from PACU, up to 18 hours from admission to the PACU]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

Principal Investigator: Frank Weinhold, Pharm.D., MS, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frank E Weinhold Pharm.D., M.S., Principal Investigator, University of Kansas Medical Center

ClinicalTrials.gov Identifier:

NCT04635774

Other Study ID Numbers:

STUDY00146489

First Posted:

Nov 19, 2020

Last Update Posted:

May 3, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Frank E Weinhold Pharm.D., M.S., Principal Investigator, University of Kansas Medical Center

Insulin

Additional relevant MeSH terms:

Delirium

Insulin

Study Results

No Results Posted as of May 3, 2022