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

Suspended

Conditions: E87
Multiple Organ Failure
N17
K72
Acute renal failure
Hepatic failure, not elsewhere classified
Other disorders of fluid, electrolyte and acid-base balance

Registration Number: DRKS00017068

Lead Sponsor: ADVITOS GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 282

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

No patients will be excluded.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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