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临床试验/CTRI/2025/02/080503
CTRI/2025/02/080503尚未招募Unknown

THERAPEUTIC DRUG MONITORING OF ANTIMICROBIALS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN CRITICALLY ILL PATIENTS

Dr.Abdul Rasheed Razia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
to estimate the Plasma concentration of the administered drug

研究概览

简要总结

BACKGROUD: The burden of infection is high in the intensive care unit (ICU) even after the consumption of antimicrobial agents (antibacterials, antifungals and antivirals). Hence, it is essential to optimise the use of antimicrobial agents not only to maximize therapeutic success but also to prolong the lifespan. For optimum clinical efficacy, Therapeutic drug monitoring (TDM) can be done which is the clinical practice of measuring specific drugs at designated intervals to maintain a constant concentration in a patient’s bloodstream, thereby optimizing individual dosage regimens. TDM also helps to review pharmacokinetics (PK) and pharmacodynamics (PD) of antimicrobials which can limit the emergence of resistance.  OBJECTIVE: 1. To identify the most commonly used antimicrobials in ICU. 2. To do therapeutic drug monitoring of antimicrobials by HPLC thereby estimating the plasma concentration of the given drug 3. To describe how TDM can be utilized to improve critically ill patient outcomes from severe infections**MATERIALS AND METHODS:**This study will be initiated after approval from IEC. Written informed consent will be obtained. STUDY POPULATION: patients admitted in ICU above 18 satisfying inclusion and exclusion criteria. SAMPLE SIZE: 100 calculated using sample size & statistics software based on previous study. STUDY SITE: Melmaruvathur Adhiparasakthi Institute of Medical Sciences And Research STUDY DURATION: 3 years **STUDY CHEMICALS:**Will be purchased from HI-MEDIA, SIGMA ALDRICH, MI.**INSTRUMENTATION AND CHROMATOGRAPHIC CONDITIONS:**Shimadzu HPLC CBM-20A SAMPLING TIME: TDM with two samples drawn at 1 (30-mins post completion of drug infusion) and 6–22 hours post administration **SAMPLE PREPARATION AND VALIDATION:**will be done as per the instrument manual. Specially designed case proforma will be used to collect all the relevant data.  STATISTICAL ANALYSIS: HPLC allows description of peak concentrations and AUC using linear regression. The results will be tabulated and analyzed using SPSS 22.0. **CONCLUSION:**This research willprovide a practical guide on how TDM can be applied in routine clinical practice to improve therapeutic outcomes, thereby minimizing the risk and toxicity in critically patients KEYWORDS: TDM, Antimicrobials, Pharmacokinetics, Pharmacodynamics

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • ICU patients Started on fresh IV antibiotics after test dose.

排除标准

  • Patients on oral antimicrobials Patients with TB/HIV Sudden switch over to antibiotics without washout period.

结局指标

主要结局

to estimate the Plasma concentration of the administered drug

时间窗: 30 mins post drug administration | trough level

次要结局

  • To look for Drug toxicity in plasma concentration(at the time of sample analysis by HPLC)

研究者

发起方
Dr.Abdul Rasheed Razia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Abdul Rasheed Razia

Melmaruvathur Adhiparasakthi institue of medical sciences and research

研究点 (1)

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