Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units

Critical Illness Clinical Trial

— HEPATICUS-2  

Official title:

Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079104
• Other study ID #: CS002
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2019
• Source: Hepa Wash GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Bilirubin = 2 mg/dl AND

2. SOFA-score = 9 calculated 12 hours after initiating medical resuscitation measures AND

3. Patient is in the intensive care unit AND

4. Signed informed consent of the patient or legal representative AND

5. Patients are 18 years or older AND

6. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).

Exclusion Criteria:

1. Patient with known history of chronic liver disease

2. Untreatable extrahepatic cholestasis

3. Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.

4. PaO2/FIO2 = 100 mmHg

5. Patients on kidney dialysis

6. Patients with MELD-score of 40

7. Mean arterial pressure = 50 mmHg despite conventional medical treatment

8. Patient testament excludes the use of life-prolonging measures

9. Post-operative patients whose liver failure is related to liver surgery

10. Uncontrolled seizures

11. Active or uncontrolled bleeding

12. Weight = 120 kg

13. Pregnancy

14. Patient diagnosed with Creutzfeldt-Jakob disease

15. Participation in another clinical study

Related Conditions & MeSH terms

• Critical Illness
• Liver Diseases
• Liver Dysfunction

Intervention

Device:
• Hepa Wash
Intervention frequency: 1-10 treatments (decision of the investigator) Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)

Procedure:
• Standard Medical Therapy
Standard of care treatment

Locations

Country	Name	City	State
Germany	II Medizinische Klinik, Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Hepa Wash GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate	Mortality 30 days after the first intervention	30 days
Secondary	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.	72 hours
Secondary	Adverse Events	Adverse Events during the intervention will be assessed	30 days
Secondary	Number of days on ventilation	Number of days with need of mechanical ventilation after first intervention	30 days
Secondary	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
Secondary	180d-mortality rate	Mortality 180 days after the first intervention	180 days
Secondary	1y-mortality rate	Mortality 1 year after the first intervention	1 year