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临床试验/NCT05542771
NCT05542771招募中不适用

External Validation of the Beta-lactam Target Non-attainment (BATMAN) Risk Score in Adult ICU Patients: a Diagnostic Multivariate Predictive Risk Model

Chantal Kats6 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
6
主要终点
Discrimination

研究概览

简要总结

Intensive care (IC) patients regularly get infections. Sometimes it is even the reason of admission to the intensive care unit. To treat these infections, we give medicines called antibiotics, such as β-lactams antibiotics. Every IC patient receives the same dose of β-lactams antibiotics, while we know this can lead to undertreatment in some IC patients. The BATMAN risk score was created to predict which IC patient is undertreated. This study aims to validate the BATMAN risk score so it can be used in clinical practice.

详细描述

In order to predict which intensive care unit (ICU) patients are not likely to achieve target attainment of beta-lactam antibiotics, a diagnostic multivariable prediction model was developed using random forest analysis. Gender, age, creatinine, and type of beta-lactam antibiotic were included in the final model and translated into a user-friendly and easy-to-implement risk score. As the name suggests, the beta-lactam target non-attainment (BATMAN) risk score predicts which adult ICU patients fail to achieve target attainment and intents efficient use of TDM of beta-lactam antibiotics. In order to use the BATMAN risk score in as many hospitals as possible in clinical practice, an external validation will be performed by a multicenter prospective observational study. All adult ICU patients admitted to the participating hospitals that are treated with beta-lactam antibiotics will be screened for eligibility. One beta-lactam trough plasma concentration, clinical and non-clinical data will be collected prospectively. To our knowledge, no other beta-lactam target non-attainment risk score for adult ICU patients has yet been developed let alone externally validated. This research is essential because ICU patients are a highly heterogenic group of patients that undergo extensive physiological alterations that will have impact on antibiotic pharmacokinetics, such as beta-lactam antibiotics. For the beta-lactams, achievement of an adequate drug level is associated with a higher likelihood of clinical success and a decrease in the potential for antimicrobial resistance. Yet, target attainment remains a challenge with the traditional 'one-dose-fits-all' strategy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Pregnancy
  • Beta-lactam antibiotic cessation before blood sample collection
  • Receiving beta-lactam antibiotic only as prophylaxis within the context of Selective Digestive tract Decontamination (SDD)
  • Patients with renal replacement therapy
  • Patients with burn injury

结局指标

主要结局

Discrimination

时间窗: Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

The discrimination of the diagnostic risk score will be displayed in the concordance index (c-index), which is identical to the area under the receiver operating curve (AUROC), where the true positive rate (y-axis) will be plotted against the false positive rate (x-axis).

Calibration

时间窗: Target attainment prediction based on the BATMAN risk score is calculated with patient data within 36 hours after of start therapy. Target attainment based on serum levels are based are measured within 36 hours after start of therapy.

The calibration of the risk score will be assessed with a calibration plot, where the average predicted risk of target non-attainment is compared with the overall event rate of target non-attainment.

次要结局

未报告次要终点

研究者

发起方
Chantal Kats
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Chantal Kats

MSc Chantal Kats, coordinating researcher (Sponsor is Erasmus Medical Center)

Erasmus Medical Center

研究点 (6)

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