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临床试验/CTRI/2024/07/069831
CTRI/2024/07/069831已完成不适用

An open-label, randomized, pragmatic clinical trial comparing the current clinical practices to pharmacologist guided optimization of antimicrobial therapy based on average creatinine-urea clearance in critically ill patients - A Pilot study

All India Institute of Medical Sciences, Raipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in SOFA score from baseline (delta SOFA score)

研究概览

简要总结

Antimicrobial therapy plays essential role in the management of patients admitted in the critical care unit. There is a considerable variation in the hemodynamics of critically ill patients. They may experience acute kidney injury or augmented renal clearance during their course of stay. This hemodynamic instability affects the pharmacokinetics of the administered antimicrobial agents which are primarily exhibit renal elimination. This leads to unstable therapeutic concentration which can result in therapeutic failure or toxicity leading to adverse reactions. Dose adjustment is usually done by calculating estimated glomerular filtration rate (eGFR) which is often unreliable in critically ill patients. Calculating the GFR using average of urine urea and creatinine clearance and optimizing dose according to this is found superior to eGFR in various studies. Our hypothesis is ’What is the effectiveness of Pharmacologist guided optimization of antimicrobial therapy based on average creatinine-urea clearance on clinical outcomes in critically ill patient admitted in critical care unit ?’. Therefore, our aim is to evaluate the effectiveness of average creatinine-urea clearance in optimization of antimicrobial therapy in critically ill patients admitted in Critical care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age 18-75 both sexes Patients admitted to the critical care unit (CCU) Expected to stay more than 24 hours in CCU Receiving at least one antimicrobial agent having renal clearance Patient randomized to the intervention arm giving consent to collect 8-hour urine for average creatinine-urea clearance estimation.

排除标准

  • Chronic Kidney disease (CKD) AKI on CKD Patient not on renal replacement therapy at the time of enrollment Clinical suspicion for Rhabdomyolysis Pregnancy or breastfeeding.
  • Patients enrolled in other interventional clinical trials simultaneously.

结局指标

主要结局

Change in SOFA score from baseline (delta SOFA score)

时间窗: baseline, day 3, and day 7

次要结局

  • Number of events of optimization of antimicrobial therapy(Period of ICU stay)
  • Length of ICU stay(day of ICU admission to day of discharge/transfer out/death)
  • 28-day all cause in-hospital mortality(Day 28)
  • Antimicrobial consumption rate(period of ICU stay)
  • Acceptance rate of recommendations given for optimization of antimicrobial therapy(Day 1 to Day 7)
  • Clostridium difficile infection rate(period of ICU stay)
  • Ventilator free days(Period of ICU stay)
  • Switch of parenteral to oral route(Period of ICU stay)
  • ARCTIC score(Period of ICU stay)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sanjeev Khanth P E

All India Institute of Medical Sciences, Raipur

研究点 (1)

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