Trial document





This trial has been registered retrospectively.
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  DRKS00017068

Trial Description

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Title

A NON-INTERVENTIONAL, MULTI-CENTER, NON╦ŚRANDOMISED PATIENT REGISTRY FOR POST╦ŚMARKETING SURVEILLANCE OF MULTIPLE ORGAN DIALYSIS

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Trial Acronym

EMOS - REGISTRY

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URL of the Trial

https://www.hepawash.com/en/emos-registry/

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Brief Summary in Lay Language

This is a patient registry to collect data on real-life treatment conditions for patients for whom multiple organ support is indicated. This information should help to improve the treatment of these seriously ill patients in the future and help to answer the following questions:

1. Performance and safety of the process;
2. Mortality during ADVOS therapy;
3. Creation of guidelines for multi-organ support;
4. Need for support measures;
5. Need for diagnostic procedures;
6. Comparison of adverse effects, mortality rates and treatment procedures with already published data

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Brief Summary in Scientific Language

In this registry, the hemodialysis device ADVOS multi will be used for extracorporeal multiple organ dialysis to support liver and kidney function which is in line with the intended use being defined for this medical device in accordance with its CE mark.
This registry will be performed under routine conditions and without any study-specific intervention, diagnostic procedures, or assessments.
Patients requiring multiple organ dialysis, for conditions such as multiple organ failure or organ transplantation or other medical reasons, will be enrolled in the registry. Data on clinical laboratory tests, health status, liver function, vital signs, and examinations will be collected before (Baseline) and after the first multiple organ dialysis as well as on Days 1, 3, and 7 after the first multiple organ dialysis, and once immediately after the last treatment of the same treatment cycle (i.e. with < 1 week of treatment interruption). ADVOS treatment parameters will be collected once after the last treatment. Follow-up data will be collected 28 days and 90 days after the first treatment.

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017068
  •   2019/04/29
  •   [---]*
  •   no
  •   Approved
  •   16022, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Multiple Organ Failure
  •   N17 -  Acute renal failure
  •   K72 -  Hepatic failure, not elsewhere classified
  •   E87 -  Other disorders of fluid, electrolyte and acid-base balance
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Interventions/Observational Groups

  •   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 intervention, diagnostic procedures, or assessments, will be enrolled in the registry.

    If available, data on clinical laboratory tests, health status, liver function, vital signs, and examinations will be collected before (Baseline) and after the first multiple organ dialysis as well as on Days 1, 3, and 7 after the first multiple organ dialysis, and once immediately after the last treatment of the same treatment cycle (i.e. with < 1 week of treatment interruption). ADVOS treatment parameters will be collected once after the last treatment. Follow-up data will be collected 28 days and 90 days after the first treatment.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/01/18
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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Exclusion Criteria

No patients will be excluded.

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Addresses

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    • ADVITOS GmbH
    • Mr.  PD Dr  Bernhard  Kreymann 
    • Agnes-Pockels-Bogen 1
    • 80992  Munich
    • Germany
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    • ADVITOS GmbH
    • Mr.  Dr.  Aritz  Perez Ruiz de Garibay 
    • Agnes-Pockels-Bogen 1
    • 80992  Munich
    • Germany
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    • ADVITOS GmbH
    • Mr.  Dr.  Aritz  Perez Ruiz de Garibay 
    • Agnes-Pockels-Bogen 1
    • 80992  Munich
    • Germany
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Sources of Monetary or Material Support

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    • ADVITOS GmbH (ehemals Hepa Wash GmbH)
    • Agnes-Pockels-Bogen 1
    • 80992  Munich
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.