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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01079091

Acute on Chronic Hepatic Failure

TERMINATED NA

HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification

NCT03312036

Liver Failure, Acute Liver Failure, Acute on Chronic

COMPLETED NA

The Influence of Paracentesis on Intra-abdominal Pressure and Kidney Function in Critically Ill Patients With Liver Cirrhosis and Ascites: an Observational Study

NCT01091233

Critically Ill Liver Cirrhosis Ascites

WITHDRAWN

Molecular Adsorbent Recirculating System (MARS®) in Hypoxic Hepatitis

NCT01690845

Hypoxic Hepatitis Ischemic Hepatitis Shock Liver +2 more

UNKNOWN PHASE2

Efficacy of High Dose Albumin Therapy in Improving Liver Transplant-free Survival in Patients With Acute Decompensation of Cirrhosis

NCT05956197

Decompensated Cirrhosis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Dysfunction Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Standard Medical Therapy

Group Type ACTIVE_COMPARATOR

Standard Medical Therapy

Intervention Type PROCEDURE

Standard of care treatment

Hepa Wash

Treatment with the liver support system "Hepa Wash"

Group Type EXPERIMENTAL

Hepa Wash

Intervention Type DEVICE

Intervention frequency: 1-10 treatments (decision of the investigator)

Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hepa Wash

Intervention frequency: 1-10 treatments (decision of the investigator)

Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)

Intervention Type DEVICE

Standard Medical Therapy

Standard of care treatment

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hepa Wash procedure the HIP1001 system

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No