NCT01079104

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

March 1, 2010

Last Update Submit

July 8, 2019

Conditions

Liver DysfunctionCritical Illness

Keywords

Liver failureHepatic insufficiencyArtificial liverAlbumin 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 the Sequential Organ Failure Assessment (SOFA) Score

    72 hours

  • Adverse Events

    30 days

  • Number of days on ventilation

    30 days

  • Number of days without extracorporeal treatment

    30 days

  • 180d-mortality rate

    180 days

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard Medical Therapy

Procedure: Standard Medical Therapy

Hepa Wash

EXPERIMENTAL

Treatment with the liver support system "Hepa Wash"

Device: Hepa Wash

Interventions

Hepa WashDEVICE

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
Hepa Wash
Standard Medical TherapyPROCEDURE

Standard of care treatment

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilirubin ≥ 2 mg/dl AND
  • SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND
  • Patient is in the intensive care unit AND
  • Signed informed consent of the patient or legal representative AND
  • Patients are 18 years or older AND

You may not qualify if:

  • Patient with known history of chronic liver disease
  • 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
  • Patients on kidney dialysis
  • Patients 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
  • Participation in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 28209134RESULT

MeSH Terms

Conditions

Liver DiseasesCritical IllnessLiver FailureHepatic Insufficiency

Condition Hierarchy (Ancestors)

Digestive System DiseasesDisease AttributesPathologic ProcessesPathological 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

August 1, 2013

Study Completion

October 1, 2013

Last Updated

July 9, 2019

Record last verified: 2019-07

Locations

DE(1)