A Multicentric, Randomised Controlled Clinical Trial to Study the Impact of Bedside Model-informed Precision Dosing of Vancomycin in Critically Ill Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 7
- 主要终点
- Proportion of patients reaching target 24hAUC/MIC
研究概览
简要总结
The overall objective of this project is to investigate the large-scale utility of MIPD of vancomycin at point-of-care in ICU children. This evaluation includes a comparison with the more standard approach on Clinical and patient-oriented measures.
详细描述
Vancomycin is an antibiotic with a narrow therapeutic-toxic margin. This means that the minimum and maximum target blood target levels differ little from each other. Too low concentrations will reduce the effect of the antibiotic; higher concentrations may result in serious side effects, including renal toxicity. Vancomycin dosing tailored to the critically ill child is challenging.
Currently, the starting dose of vancomycin is calculated on a milligram per kilogram basis, which is the same for all patients. The dose is then adjusted based on a measured vancomycin blood concentration (if too high or too low). Despite this measurement, quickly achieving target concentrations remains a major challenge.
This multicenter, individual randomized study investigates the added value of a user-friendly computer program for calculating the vancomycin dose in critically ill children, compared to the current standard-of-care. Specifically, the investigators will study whether the use of this computer program leads to a shorter time to reach target concentrations, a reduction in the number and severity of side effects on the kidney, a reduction in patient burden, and a reduction in time to cure and duration of hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
participants and parents or legal representatives are blinded for the allocation to the intervention or standard-of-care arm until the end of study.
the statistician is kept blinded until after data analysis.
入排标准
- 年龄范围
- 0 Days 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 0-18 years
- •admitted to ICU or PHO unit
- •suspected or confirmed Gram positive infection
- •planned to start on intravenous intermittent or continuous infusion vancomycin treatment
- •informed consent signed by parents or legal representatives
- •not previously enrolled in this trial
排除标准
- •extracorporeal treatment at inclusion or started during treatment (extracorporeal membrane oxygenation, dialysis, body cooling)
- •n or p RIFLE category failure at inclusion (Day 0) (see section 8.1.
- •Known chronic kidney disease as defined by the KDIGO definition as: structural or functional abnormalities of the kidney regardless of GFR for < 3 months or GFR < 60ml/min/1.73m² for ≥ 3 months. eGFR is estimated using the modified Schwartz equation
- •patient death is deemed imminent and inevitable
研究组 & 干预措施
Standard of Care Vancomycin treatment
Vancomycin standard-of-care dosing and therapeutic drug monitoring, according to institutional guidelines during 30 day study period
干预措施: Vancomycin (Drug)
vancomycin model-informed precision dosing
Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period
干预措施: vancomycin model-informed precision dosing (Device)
vancomycin model-informed precision dosing
Area Under the Concentration (AUC)-time curve/MIC-based model-informed precision dosing of vancomycin using a CE labelled dosing calculator during 30 day study period
干预措施: Vancomycin (Drug)
结局指标
主要结局
Proportion of patients reaching target 24hAUC/MIC
时间窗: 24 to 48 hours after start vancomycin treatment
therapeutic AUC/MIC target range is 400-600
次要结局
- Proportion of patients with (worsening) acute kidney injury during vancomycin treatment(from start date of vancomycin treatment until stop date vancomycin treatment or study day 30, whichever comes first)
- Proportion of patients reaching target 24h AUC/MIC(48-72 hours after start vancomycin treatment)
- Time to clinical cure(30 day study period)
- Ward unit length-of-stay(30 day study period)
- Hospital length-of-stay(30 day study period)
- 30 day all cause mortality(30 day study period)