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临床试验/CTRI/2022/09/045611
CTRI/2022/09/045611已完成4 期

"Drug-Drug Interactions and Prescription Appropriateness in COVID-19 ICU Patients in a Tertiary Care Hospitalâ€

ESIC Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2022年9月26日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
191
试验地点
1
主要终点
To assess the frequency and severity of potential DDIs in COVID-19 ICU patients

研究概览

简要总结

With the investigational therapies and in addition to specific therapy for COVID-19 patients; the overall pharmacological burden may pose an extremely high risk of potential drug drug interactons (pDDIs), prescription inappropriate medications (PIMs) and drug specific adverse events. Therefore an optimized and safer prescription practice in multiple co-morbid conditions and older individuals is often a difficult task.

However, to address these issues, various computerized prescriptions support systems have been developed and one such is INTERCheck® which stores information on explicit criteria for PIMs, anticholinergic load, potential DDIs, dose adjustment in cases of renal impairment and modality for drug withdrawals (dose tapering). With limited data in Indian context which addresses the burden of DDIs and PIMs in COVID-19 ICU patients, the present study aims to evaluate the pattern of DDIs, pharmacological burden and PIMs upon admission and during hospitalization.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • •Case record of all adult patients with proven diagnosis of SARS-CoV-2 infection (a throat swab positive for viral nucleic acid) admitted to the COVID-19 ICU during the study period and treated with at least two drugs will be considered.

排除标准

  • •Patients transferred to other wards from ICU or discharged/death within 24hr of admission will be excluded.

结局指标

主要结局

To assess the frequency and severity of potential DDIs in COVID-19 ICU patients

时间窗: March to July 2021

次要结局

  • To evaluate PIMs in the subset of patients aged more than or equal to 65 years(March to July 2021)

研究者

发起方
ESIC Medical College and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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