Immunoparalysis in Septic Shock, Sepsis, Septic Shock
Conditions
Keywords
Sepsis, septic shock, Immunoparalysis in Septic Shock
Brief summary
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.
Interventions
None listed
Sponsors
Artcline GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥ 18 years who are planned to receive ARTICE® treatment during their ICU stay
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SOFA score D0 to SOFA Score D7 (or after last ARTICE® treatment, if later as D7). | 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. | 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. | 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. | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Apache II Score. | 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). | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Mechanical ventilation days. | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Renal replacement therapy days. | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Vasopressor therapy days. | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Frequency of secondary infections. | From enrollment up to 7 days after last ARTICE® treatment. | — |
| Type of secondary infections: it will be divided into viral, bacterial or fungi infection. | 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. | 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. | 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. | 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. | 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. | From enrollment up to 7 days after last ARTICE® treatment. | — |
Countries
Germany
Contacts
CONTACTJens Altrichter, Dr. med.
CONTACTJudith Hey, M. Sc.
PRINCIPAL_INVESTIGATORMartin Sauer, Prof. Dr. med.
Klinikum Magdeburg, Klinik für Intensiv- & Rettungsmedizin
Outcome results
None listed