| CTRI Number |
CTRI/2025/10/095710 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on how AI and doctors agree on safe medicines and doses for ICU patients |
|
Scientific Title of Study
|
An Observational Longitudinal Study to Explore the Concordance between an Advanced Generative AI Model, Live Clinical Prescription, and a Gold Standard Prescription of Drug Appropriateness, Dosing, and Drug-Drug Interactions in a Medical ICU. |
| Trial Acronym |
AIM-ICU (AI in Medication Safety – ICU Study) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushila Kataria |
| Designation |
Vice chairman, Department of Internal Medicine |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
9818828078 |
| Fax |
|
| Email |
Sushila.Kataria@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushila Kataria |
| Designation |
Vice chairman, Department of Internal Medicine |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram
HARYANA
122001
India |
| Phone |
9818828078 |
| Fax |
|
| Email |
Sushila.Kataria@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushila Kataria |
| Designation |
Vice chairman, Department of Internal Medicine |
| Affiliation |
Medanta The Medicity |
| Address |
Medanta The Medicity, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram
HARYANA
122001
India |
| Phone |
9818828078 |
| Fax |
|
| Email |
Sushila.Kataria@medanta.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta- The Medicity |
| Address |
CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram, Haryana 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sushila Kataria |
Medanta The Medicity |
CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38, Gurugram
Gurgaon
HARYANA |
09818828078
Sushila.Kataria@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients admitted to the Medical ICU at Medanta The Medicity with ICU stay more than or equal to 6 hours whose retrospective prescription data is available through eHIS for at least 5 days |
|
| ExclusionCriteria |
| Details |
ICU stay less than 6 hours
Patients admitted with poisoning or snake bite
Trauma patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number and severity of clinically significant DDIs |
Within 5 days of ICU stay (daily prescription review) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Instances of inappropriate drug, dose, frequency, or duration.
Concordance rates between AI, live clinician and gold standard
|
Within 5 days of ICU stay (daily prescription review) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2025 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Short Description / Primary Purpose & Hypothesis
This study aims to compare prescriptions generated by an advanced generative AI model with live clinician prescriptions and gold standard prescriptions in a Medical ICU. The primary purpose is to evaluate concordance in drug appropriateness, dosing, and identification of drug–drug interactions.
Hypothesis: AI-assisted prescription review will reduce inappropriate drugs, clinically significant drug–drug interactions, and dosing errors compared to conventional clinician-driven prescriptions, thereby improving medication safety. |