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临床试验/NCT07230041
NCT07230041招募中不适用

In Vivo Antibiotics Removal During Treatment With Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit

Niguarda Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
drug concentration

研究概览

简要总结

The purpose of this study is to measure the change in plasma concentrations of antibiotics used during passage through the CRRT filter and hemadsorption cartridge in patients with septic shock and renal failure requiring CRRT.

All patients aged > 18 years, admitted to the ICU, diagnosed with septic shock and renal failure requiring CRRT, receiving antibiotic therapy with at least one of the following drugs: meropenem, linezolid, and daptomycin, who provided informed consent, are included in the study.

Patients not admitted to the ICU, patients with renal failure not requiring CRRT, patients aged < 18 years, or those who did not provide informed consent are excluded. The enrollment period will last 12 months and will run from September 2024 to September 2025. The expected number of patients enrolled is twenty. To proceed with the study, after starting antibiotic therapy, a 4 ml dose of blood will be drawn (Vacuette tube ref. 454092) before the cartridge, immediately after, and after the dialysis filter. This measurement will be repeated after 4, 8, and 12 hours, which represents the maximum usage time of the cartridge.

After 12 hours, the cartridge becomes saturated and loses its adsorption capacity.

The CRRT filter, however, remains in place for at least 72 hours before being replaced. Treatment is maintained until clinically necessary.

For patients in intensive care, several blood samples are required throughout the day, both with a blood sample sent to the biochemistry laboratory every 6-8 hours to check clinical conditions, and with an arterial blood sample (blood gas) to check respiratory and metabolic status in patients on mechanical ventilation. Furthermore, in patients undergoing CRRT, electrolyte balance must be monitored every 4 hours. Therefore, the blood sample for the study inevitably coincides with one of the routine blood samples.

The test tube, labeled with a unique code, will be sent to the central laboratory, which will centrifuge the blood and extract the plasma. This aliquot will then be stored at -80°C in a dedicated space and sent to the designated laboratory upon analysis.

Determination of the plasma dosage of the antibiotic in use is commonly performed on patients admitted to the Intensive Care Unit, where clinically necessary. Participation in the study does not change current clinical practices.

详细描述

In ICU setting, most empiric antibiotic treatments include a combination of anti-Gram-positive and -negative bacteria, according to the different clinical scenarios. Thus, there are different possible regimen combinations, including two different drugs. We considered meropenem/linezolid (or daptomycin) as the drugs of choice in septic shock empiric treatment.

The motivation for the use of HA380 was to remove inflammatory cytokines. Only one HA 380 application (=12 hours) will be evaluated in this study.

Hemadsorption will be performed using a BBraun OMNI machine: a Jafron HA380 cartridge is assembled in series with a BBraun OMNI PLUS 'open' filter.

Hemadsorption lasts from 2 to 12 hours maximum, at the end the cartridge can be disassembled and CRRT treatment alone can be carried forward.

CRRT is performed according to the Omni machine BBraun protocol . CVVHD is the technique of choice because the diffusion method guarantees membrane stability.

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

  • stage 3 KDIGO consensus criteria, indication to CRRT
  • use of at least one of the following antibiotics meropenem, linezolid and daptomycin

排除标准

  • 未提供

研究组 & 干预措施

ICU patients with a diagnosis of infection/sepsis/septic shock

  • stage 3 KDIGO consensus criteria, indication to CRRT
  • use of at least one of the following antibiotics meropenem, linezolid and daptomycin

干预措施: Liquid Chromatography - Tandem Mass Spectrometry (Diagnostic Test)

结局指标

主要结局

drug concentration

时间窗: 4 hours

assess the percentage of drug concentration variation pre and post HA 380 cartridge

次要结局

  • drug concentration variation(8 and 12 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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