| CTRI Number |
CTRI/2025/05/087534 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of Intranasal Insulin in the prophylaxis of ICU Delirium |
|
Scientific Title of Study
|
Efficacy of Intranasal Insulin in the prophylaxis of ICU Delirium: A Single center double blined prospective randomized trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEGHNA KAHLON |
| Designation |
Junior Resident academic |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and intensive care
POst graduate institute of medical education and research
CHANDIGARH
Department of Anesthesia and Intensive care
PGIMER
CHANDIGARH
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8626877554 |
| Fax |
|
| Email |
meghnakahlon999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIKAS SAINI |
| Designation |
Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department of Anesthesia and Intensive care
Post graduate institute of medical education and research
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIKAS SAINI |
| Designation |
Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Department of Anesthesia and Intensive care
Post graduate institute of medical education and research
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research
CHANDIGARH
Sector 12
160012
Chandigarh
Sector 12
160012 |
|
|
Primary Sponsor
|
| Name |
DrMeghna Kahlon |
| Address |
Department of Anesthesia and Intensive care
Post Graduate Institute of Medical Education and Research
CHANDIGARH
160012 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MEGHNA KAHLON |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
Level 4
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
SECTOR 12
CHANDIGARH
160012
Chandigarh
CHANDIGARH |
08626877554
meghnakahlon999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Insulin |
Long acting Intranasal Insulin 20 IU to be administered twice daily in ICU patients for the period of 10 days or till discharge from ICU whichever is earlier |
| Comparator Agent |
Normal Saline |
Normal Saline to be administered intranasally twice daily in the control group for the period of 10 days or till discharge from ICU whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female aged 18-70 years with expected ICU stay of more than 24 hours |
|
| ExclusionCriteria |
| Details |
Already delirious or pre-existing cognitive dysfunction
Pregnant patients
Patients with irreversible brain damage or acute brain injury
Hepatic encephalopathy or liver cirrhosis with a Child Pugh Score B or C
Comatose patients who cannot be assessed for delirium
Patients in whom intranasal drug administration is contraindicated
Patients with hypoglyceamia at the tme of presentation
RASS -4 OR -5 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of delirium |
Within the first 10 ICU days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The number of positive CAM-ICU counts
Duration of delirium
Duration of mechanical ventilation
Length of ICU stay
Length of hospital stay
Duration of intubation
Successful extubation
Need for antipsychotics/sedatives and dosages used
ICU mortality
Any adverse side effects due to intranasal insulin |
within the period of 10 days or discharge |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Delirium is a sudden and severe state of confusion characterized by fluctuating disruptions in cognitive function and attention.The prevalence of delirium varies widely in the intensive care unit affecting 11% and 83% of patients. Its occurence is associated with increased mortality and prolonged ICU stays.Prevention and management remains a tough problem because of side effects and limited effiacy of treatment options.No evidence based pharmacological therapies have been proven efficacious in treatment of delirium.
Intranasal insulin has recently emerged as a promising approach for preventing and treating perioperative neurocognitive disorders, showing effectiveness without reported side effects. Intranasal insulin administration at doses of 160 units has demonstrated improvements in memory function and brain metabolism in patients with cognitive dysfunction and delirium without causing hypoglycemia. it bypasses the blood brain barrier and elevates insulin levels in the cerebrospinal fluid without entering the bloodstream or causing systemic metabolic effects.
The replicability and applicability of these proposed benefits of intranasal insulin is still unclear in critical care.in this study, we try to answer if intranasal insulin reduces the prevalence of delirium in a population of critically ill patients compared with usual care |