ARTISTRY - ARTICE® Therapy Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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:
- Record real-life data related to the use of the ARTICE® therapy in sepsis subjects.
- Further evaluate ARTICE® treatment efficacy.
- Identify potential sub-groups, assess their risk-benefit- and safety profile.
- 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
- 否
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
