Post Operative Delirium Study (PODS)

• ClinicalTrials.gov Identifier: NCT04635774
• Recruitment Status: Recruiting
• First Posted: November 19, 2020
• Last Update Posted: May 10, 2021
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): Frank E Weinhold Pharm.D., M.S., University of Kansas Medical Center

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 (Clinical Trial)
• Estimated 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.

• 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: February 25, 2021
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2022

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).

Outcome Measures

Primary Outcome Measures :

1. Efficacy of intranasal insulin in resolving post-operative delirium [ Time Frame: 10 min post diagnosis ]
   Measured by administering the Confusion Assessment Method (CAM) tool
2. Efficacy of intranasal insulin in resolving post-operative delirium [ Time Frame: 30 min post diagnosis ]
   Measured by administering the Confusion Assessment Method tool
3. Efficacy of intranasal insulin in resolving post-operative delirium [ Time Frame: 60 min post diagnosis ]
   Measured by administering the Confusion Assessment Method tool
4. Efficacy of intranasal insulin in resolving post-operative delirium [ Time Frame: 6 hours post diagnosis ]
   Measured by administering the Confusion Assessment Method tool

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Angie Ballew, DC, MS; 9139457420; aballew@kumc.edu

Contact: Manuel Clark, MPA; 913-945-5763; mclark16@kumc.edu

Locations

United States, Kansas

University of Kansas Medical Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: Frank Weinhold, PharmD 913-588-9900 weinhold@ku.edu

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

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

More Information

• 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: November 19, 2020
• Last Update Posted: May 10, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

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

Insulin

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs