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临床试验/CTRI/2025/10/095710
CTRI/2025/10/095710招募中不适用

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.

Medanta- The Medicity1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Number and severity of clinically significant DDIs

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • ICU stay less than 6 hours Patients admitted with poisoning or snake bite Trauma patients.

结局指标

主要结局

Number and severity of clinically significant DDIs

时间窗: Within 5 days of ICU stay (daily prescription review)

次要结局

  • Instances of inappropriate drug, dose, frequency, or duration.(Concordance rates between AI, live clinician and gold standard)

研究者

发起方
Medanta- The Medicity
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Sushila Kataria

Medanta The Medicity

研究点 (1)

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