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The foundations of our pilotstudy planning has changed.
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Patients with hepatic dysfunction are known to have a high mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with hepatic dysfunction in the intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard Medical Therapy |
|
| Hepa Wash | Experimental | Treatment with the liver support system "Hepa Wash" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepa Wash | Device | Intervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality rate | Mortality 30 days after the first intervention | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score | The Sequential Organ Failure Assessment (SOFA) Score analyses the severity of illness according to 6 organ systems (CNS, Liver, Kidney, Hemodynamic, Coagulation, Lung). Each system is given 0 to 4 points for a total of 24 points. A value >2 in each of the systems indicates organ failure. An overall value > 14 indicates 90% probability of in-hospital mortality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Huber, PD Dr. | II Medizinische Klinik, Klinikum rechts der Isar, Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| II Medizinische Klinik, Klinikum rechts der Isar | Munich | Bavaria | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28209134 | Result | Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D016638 | Critical Illness |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard Medical Therapy | Procedure | Standard of care treatment |
|
| 72 hours |
| Adverse Events | Adverse Events during the intervention will be assessed | 30 days |
| Number of days on ventilation | Number of days with need of mechanical ventilation after first intervention | 30 days |
| Number of days without extracorporeal treatment | Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention | 30 days |
| 180d-mortality rate | Mortality 180 days after the first intervention | 180 days |
| 1y-mortality rate | Mortality 1 year after the first intervention | 1 year |