- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314125
ChatGPT-5 vs. CDSS for Drug-Drug Interactions in ICU
Evaluating ChatGPT-5 for Detecting Potential Drug-Drug Interactions in Intensive Care: A Comparative Analysis With a Clinical Decision Support System
Evaluating ChatGPT-5 for Detecting Potential Drug-Drug Interactions in Intensive Care: A Comparative Analysis with a Clinical Decision Support System
Background:
Polypharmacy is a frequent challenge in intensive care units (ICUs), where critically ill patients are exposed to multiple concurrent medications. This situation significantly increases the risk of potential drug-drug interactions (pDDIs), which may contribute to adverse drug events, prolonged ICU stays, and higher morbidity and mortality rates. Ensuring timely and accurate detection of pDDIs is therefore a cornerstone of patient safety in critical care settings. Traditional rule-based clinical decision support systems (CDSSs), such as the UpToDate Drug Interaction Checker, provide standardized alerts but may have limitations in contextual interpretation and adaptability. Recently, large language models (LLMs), such as ChatGPT-4.0, have emerged as advanced tools with natural language processing capabilities, potentially offering a novel approach to medication safety.
Objective:
This study aims to compare the performance of ChatGPT-4.0 with the UpToDate Drug Interaction Checker in identifying, classifying, and interpreting potential drug-drug interactions within real ICU patient medication orders.
Methods:
A retrospective dataset of ICU patient orders will be systematically analyzed using both ChatGPT-4.0 and the UpToDate Drug Interaction Checker. Each potential interaction will be assessed for sensitivity, specificity, accuracy, and clinical relevance. Discrepancies between the two systems will be documented and evaluated by independent critical care experts. Statistical analysis will be performed to compare detection rates and the qualitative depth of interaction explanations provided by each tool.
Expected Outcomes:
The study is expected to determine whether ChatGPT-4.0, as an AI-based system, can enhance the detection of clinically meaningful drug-drug interactions compared to traditional CDSS. The results may inform future integration of generative AI into ICU clinical workflows and contribute to safer pharmacotherapy practices in critical care.
Conclusion:
By directly comparing a state-of-the-art LLM with a widely used rule-based system, this study seeks to highlight the strengths, weaknesses, and potential clinical implications of generative AI in the domain of drug safety.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Bursa
-
Bursa, Bursa, Turkey (Türkiye), 16235
- Bursa Yuksek Ihtisas Research and Education Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or older
- Admission to the intensive care unit (ICU) for at least 48 hours
- Receipt of five or more medications concurrently during ICU stay
- Availability of complete clinical data and medication lists
Exclusion Criteria:
- Cases with incomplete medication or interaction data
- Patients receiving experimental or unproven drugs
- Pediatric patients or those with pregnancy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensitivity of pDDI Detection
Time Frame: September 1 2025 to october 1 2025
|
September 1 2025 to october 1 2025
|
|
Accuracy of Drug-Drug Interaction Detection of chatgpt
Time Frame: from seprember 1 2025 to october 1 2025
|
from seprember 1 2025 to october 1 2025
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-TBEK 2025/07-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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