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

Not Applicable

Terminated

• Conditions: Liver Dysfunction; Critical Illness

• Registration Number: NCT01079104
• Lead Sponsor: Hepa Wash GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Study Start: 2010-09
• Primary Completion: 2013-08
• Study Completion: 2013-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
30-day mortality rate	30 days	Mortality 30 days after the first intervention

Secondary Outcome Measures

Name	Time	Method
Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score	72 hours	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.
Number of days without extracorporeal treatment	30 days	Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention
Adverse Events	30 days	Adverse Events during the intervention will be assessed
180d-mortality rate	180 days	Mortality 180 days after the first intervention
Number of days on ventilation	30 days	Number of days with need of mechanical ventilation after first intervention
1y-mortality rate	1 year	Mortality 1 year after the first intervention

Trial Locations

Locations (1)

II Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany