A NON-INTERVENTIONAL, MULTI-CENTER, NON?RANDOMISED PATIENT REGISTRY FOR POST?MARKETING SURVEILLANCE OF MULTIPLE ORGAN DIALYSIS

Conditions

Multiple Organ Failure N17 K72 E87

Fuhrmann V, Tyczynski B, Perez Ruiz de Garibay A, Bingold TM, Weinmann-Menke J, Faltlhauser A, Jarczak D, Lutz J, Sander M, Klimpke P, Koch C, Kribben A, Boenisch O, Kluge S.

2025-12-04

10.1371/journal.pone.0318917

EMOS-Registry whole set tables.

Valentin Fuhrmann (124225), Bartosz Tyczynski (10113645), Aritz Perez Ruiz de Garibay (9136496), Tobias Michael Bingold (22783574), Julia Weinmann-Menke (11599233) et al. (14 authors)

OPAL (Open@LaTrobe) (La Trobe University)2025-12-04

10.1371/journal.pone.0318917.s003

Registry on extracorporeal multiple organ support with the advanced organ support (ADVOS) system

Valentin Fuhrmann, Aritz Pérez Ruiz de Garibay, Andreas Faltlhauser, Bartosz Tyczynski, Dominik Jarczak et al. (9 authors)

Medicine2021-02-1922 citations

10.1097/md.0000000000024653

Interventions

Group 1: Patients requiring extracorporeal organ support for liver and kidney function with the ADVOS hemodialysis system performed under routine conditions and without any mandatory study-specific in

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 or above; 2. Indication for multiple organ dialysis; 3. Signed informed consent form to participate in the registry. Note: For patients unable or unwilling to provide informed consent, anonymized (i.e. untraceable) data will be collected. For patients who were already treated with the ADVOS multi device, anonymized (i.e. untraceable) data will be collected retrospectively.

Exclusion criteria

Exclusion criteria: No patients will be excluded.

Design outcomes

Primary

Measure	Time frame
To compile a patient registry to collect data on real-life treatment conditions for patients for whom multiple organ dialysis is indicated. This information should help to improve the treatment of these seriously ill patients in the future	—

Secondary

Measure	Time frame
Performance: 1. Chronic liver failure-sequential organ failure assessment (CLIF-SOFA), sequential organ failure assessment (SOFA), and quick SOFA (qSOFA) scores; 2. Severity of liver disease, assessed by the Model for End-Stage Liver Disease (MELD) score; 3. Child-Pugh Score; 4. Charlson Comorbidity Index and Score for Risk; 5. Simplified Acute Physiology (SAPS) Score II; 6. Cardiac output and other hemodynamic parameters; 7. Indocyanine green dye (ICG) clearance; 8 Occurrence of ascites and hepatic encephalopathy; 9. Biochemical tests reflecting hepatocyte damage, such as total bilirubin, albumin, and creatinine; 10. Mortality rates 28 and 90 days after the first treatment. Safety: 11. Laboratory (including blood chemistry, hematology, coagulation, and urine); 12. Adverse events; 13. Assessment of breathing; 14. Vital signs; 15. Blood gas analysis, including base excess	—

Measure

Time frame

Performance: 1. Chronic liver failure-sequential organ failure assessment (CLIF-SOFA), sequential organ failure assessment (SOFA), and quick SOFA (qSOFA) scores; 2. Severity of liver disease, assessed by the Model for End-Stage Liver Disease (MELD) score; 3. Child-Pugh Score; 4. Charlson Comorbidity Index and Score for Risk; 5. Simplified Acute Physiology (SAPS) Score II; 6. Cardiac output and other hemodynamic parameters; 7. Indocyanine green dye (ICG) clearance; 8 Occurrence of ascites and hepatic encephalopathy; 9. Biochemical tests reflecting hepatocyte damage, such as total bilirubin, albumin, and creatinine; 10. Mortality rates 28 and 90 days after the first treatment. Safety: 11. Laboratory (including blood chemistry, hematology, coagulation, and urine); 12. Adverse events; 13. Assessment of breathing; 14. Vital signs; 15. Blood gas analysis, including base excess

—

Countries

Germany

Contacts

Public ContactAritz Perez Ruiz de Garibay

ADVITOS GmbH

info@advitos.com+49 89 411 18 42 0

Outcome results

None listed