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临床试验/NCT07388628
NCT07388628招募中不适用

ARTISTRY - ARTICE® Therapy Registry Study

Artcline GmbH2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月25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
Artcline GmbH
入组人数
200
试验地点
2
主要终点
Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7).

研究概览

简要总结

The objectives of this registry study are to:

  1. Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
  2. Further evaluate ARTICE® treatment efficacy.
  3. Identify potential sub-groups, assess their risk-benefit- and safety profile.
  4. Changes in SOFA score D0 to SOFA Score D7.

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

  • Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay

排除标准

  • 未提供

结局指标

主要结局

Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7).

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

SOFA Score is the Sequential Organ Failure Score providing information about mortality risk, 6 organs or organ systems are assesed using specific parameters, both the sum of the points and the point development of the individual organs can be considered, normal function of organ/organ system has 0 points, severely impacted function do have 4 point, in total you can have 0 points (every organ/organ system is normale) as a minimum and 24 points as maximum (severely impacted organ/organ system)

Changes in general SOFA score and SOFA sub scores.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

SOFA Score is the Sequential Organ Failure Score providing information about mortality risk, 6 organs or organ systems are assesed using specific parameters, both the sum of the points and the point development of the individual organs can be considered, normal function of organ/organ system has 0 points, severely impacted function do have 4 point, in total you can have 0 points (every organ/organ system is normale) as a minimum and 24 points as maximum (severely impacted organ/organ system)

Changes in standard lab and inflammatory biomarkers.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

standard lab and inflammatory biomarkers for exampample are: ferritine, total bilirubin, kreatinine, CRP, lactate, gammaglobuline, amount of the different blodd cell types, like neutrophils, lymphocytes

Hospital survival rates.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Apache II Score.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

APACHE II is a clinical rating system for evaluating the severity of an illness and the risk of death in intensive care medicine; score includes information on the patient's current condition, age and concomitant diseases, values are collected over 24 hours, highest value is included in calcutaion; the score can be at minimum 0 points (lightly risk of death) and at maximum 71 (very high risk of death)

Length of ICU stay (days).

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Mechanical ventilation days.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Renal replacement therapy days.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Vasopressor therapy days.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Frequency of secondary infections.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

Type of secondary infections: it will be divided into viral, bacterial or fungi infection.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

It is recorded whether the infection is viral, bacterial, or caused by fungi. And in case of bacterial infection it will be recorded weather, it is gram-positive or gram-negative bacterial infection.

Changes in the physiological parameter heartrate.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

as physiological parameter will be measured heartrate in bpm

Changes in physiological parameter blood pressure.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

as physiological parameter will be measured systolic and diastolic blood pressure in mmHg.

Changes in physiological parameter body temperature.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

as physiological parameter will be measured body temperature in °C

Changes in physiological parameter mean arterial pressure.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

as physiological parameter will be measured mean arterial pressure in mmHG

Complications related to the ARTICE® therapy application.

时间窗: From enrollment up to 7 days after last ARTICE® treatment.

次要结局

未报告次要终点

研究者

发起方
Artcline GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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