REGISTER FOR THE EXTRACORPORAL SUPPORT OF SEVERAL ORGAN SYSTEMS (EMOS-REGISTER)
Type of register:
Non-interventional, multi centric, non-randomized patient register as an application monitoring of ADVOS multi, a medical device approved in the EU.
Goal:
Acquisition of data on the treatment of patients under practice conditions, where multi-organ support is indicated. These data will help to improve future treatments and help to answer the following questions:
- Performance and safety of the process
- Mortality during ADVOS therapy
- Creation of guidelines for multi-organ support
- Need for support measures
- Need for diagnostic procedures
- Comparison of adverse effects, mortality rates and treatment procedures with already published data
Number of patients:
> 100 patients who meet the following inclusion criteria:
- Age > 18 years
- Indication for multi-organ support
Study centers:
At least 10 study centers within Europe
Term:
November 2016 anticipated to November 2018
Data collection:
Lab tests, health status, liver function, vital signs and examinations are done before (baseline) and after the first multi-organ support as well as on days 1, 3, and 7 after the first multi-organ support and once directly after the last treatment cycle. ADVOS treatment parameters are recorded once after the last treatment and observation data 28 days and 90 days after the first treatment.
Data evaluation:
Descriptive statistics of the following parameters:
- Various scores
- Biochemical parameters, especially for liver, kidney and lung function as well as acid-base balance
- Indocyanine green clearance
- Incidence of ascites and hepatic encephalopathy under ADVOS therapy
- Hemodynamics
- Mortality 28 and 90 days after the first treatment
- Undesired events
- Safety