Hepa Wash Treatment of Patients With Acute-on-Chronic Liver Failure in Intensive Care Units

NCT01079091 | Terminated DMC

• 1 other identifier: CS001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with compensated chronic liver disease who have an episode of acute deterioration of liver function (acute-on-chronic liver failure) are known to have up to 90% 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 acute-on-chronic liver failure in the intensive care unit.

Conditions

Acute on Chronic Hepatic Failure

Keywords

Liver failure; Hepatic insufficiency; Liver Cirrhosis; Artificial liver; Albumin dialysis

Outcome Measures

Primary Outcomes (1)

• 30-day mortality rate

  Mortality 30 days after the first intervention

  30 days

Secondary Outcomes (6)

• Multiorgan system failure according to Sequential Organ Failure Assessment (SOFA) Score

  72 hours

• Safety (adverse events and surrogate parameters)

  30 days

• Number of days on ventilation

  30 days

• Number of days without extracorporeal treatment

  30 days

• 180d-mortality rate

  180 days

Study Arms (1)

ADVOS (Hepa Wash)

EXPERIMENTAL

Treatment with the liver support system "Hepa Wash"

Device: ADVOS (Hepa Wash); Procedure: Standard Medical Therapy

Interventions

ADVOS (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)

Also known as: Hepa Wash procedure, the HIP1001 system

ADVOS (Hepa Wash)

Standard Medical Therapy PROCEDURE

Standard of care treatment

ADVOS (Hepa Wash)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented clinical or histological evidence of cirrhosis AND
• Acute decompensation in previously stable cirrhotic liver disease AND
• Bilirubin ≥ 2 mg/dl AND
• SOFA ≥ 9 calculated after 12 hours of optimal medical therapy AND
• Patient is in the intensive care unit AND
• Informed consent of the patient or the legal representative AND
• Patients are 18y or older AND

You may not qualify if:

• Untreatable extrahepatic cholestasis
• 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.
• PaO2/FIO2 ≤ 100 mmHg (respiratory SOFA-score of 4)
• Patients who receive a vasopressor support of Dopamine \>15 µg/kg/min or epinephrine \>0.1 µg/kg/min or norepinephrine \>0.1 µg/kg/min (cardiovascular SOFA-score of 4)
• Patients with creatinine ≥5 mg/dl or urine output \<200 ml/day (renal SOFA-score of 4)
• Patients on kidney dialysis
• Patient with MELD-score of 40
• Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment
• Patient testament excludes the use of life-prolonging measures
• Post-operative patients whose liver failure is related to liver surgery
• Uncontrolled seizures
• Active or uncontrolled bleeding
• Weight ≥ 120 kg
• Pregnancy
• Patient diagnosed with Creutzfeldt-Jakob disease

Sponsors & Collaborators

• Hepa Wash GmbH: lead

Study Sites (1)

II Medizinische Klinik, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

Related 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-x.

  PMID: 28209134 RESULT

MeSH Terms

Conditions

Liver Failure; Hepatic Insufficiency; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Huber, PD Dr.

  II Medizinische Klinik, Klinikum rechts der Isar, Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DE (1)