NCT06129617

Brief Summary

In the planned randomized controlled prospective pilot study, we aim to evaluate ADVOS compared with conventional hemodialysis regarding the elimination of protein-bound toxins in patients with therapy-refractory hepatorenal syndrome. The study will be performed in a regular non-ICU ward with a large experience in the use of the ADVOS therapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress98%
Jun 2023Jun 2026

Study Start

First participant enrolled

June 1, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

June 21, 2023

Last Update Submit

November 8, 2023

Conditions

Liver CirrhosisKidney Failure, AcuteKidney ReplacementMulti Organ Failure

Outcome Measures

Primary Outcomes (1)

  • course of total bilirubin in patients blood

    measurement of concentration of total bilirubin in serum of patients in mg/dl

    Within 6 hours before first treatment and within 2 hours after every treatment session

Secondary Outcomes (22)

  • course of uremia toxins in patients blood

    Within 6 hours before first treatment and within 2 hours after every treatment session

  • course of bile acids

    Within 6 hours before first treatment and within 2 hours after every treatment session

  • evaluation of safety of ADVOS versus hemodialysis

    during the five interventions

  • Quality of life raised in a standardized questionnaire

    baseline before intervention and on days 28, 90, 180

  • number of days in hospital during the intervention

    admission in our department till discharge from our deparment

  • +17 more secondary outcomes

Study Arms (2)

Hemodialysis

ACTIVE COMPARATOR

Patients receiving hemodialysis therapy mit Fresenius 5008

Device: Hemodialysis

ADVOS

EXPERIMENTAL

Patients receiving ADVOS therapy with ADVOS multi

Device: ADVOS

Interventions

HemodialysisDEVICE

5 treatments with hemodialysis on day 1, 2, 3, 5 and 7

Hemodialysis
ADVOSDEVICE

5 treatments with ADVOS on day 1, 2, 3, 5 and 7

ADVOS

Eligibility Criteria

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

You may qualify if:

  • Capacity of the patient to give consent
  • Pre-existing liver disease in the sense of an ACLF with HRS
  • Age \>18 years
  • Patient of the University Medical Center Mainz
  • Bilirubin level ≥ 4 mg/dl
  • Indication for renal replacement procedure is based on STARRT-AKI criteria (serum potassium ≥ 6 mmol/l in two independent blood samples; serum pH of 7.2 or less or serum bicarbonate of 12 mmol/l or less; respiratory failure secondary to volume excess)

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Contraindications for ADVOS therapy
  • Already started renal replacement therapy
  • Contraindication for citrate anticoagulation
  • Use of vasopressors and MAD ≤ 50 mmHg.
  • Terminal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik

Mainz, Rhineland-Palatinate, 55130, Germany

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisAcute Kidney InjuryMultiple Organ Failure

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesShock

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • Julia Weinmann-Menke, Prof.

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Weinmann-Menke, Prof.

CONTACT

0049 06131 17 2213julia.weinmann-menke@unimedizin-mainz.de

Pascal Klimpke, M.D.

CONTACT

0049 06131 17 2213pascal.klimpke@unimedizin-mainz.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of nephrology and kidney transplantation

Study Record Dates

First Submitted

June 21, 2023

First Posted

November 13, 2023

Study Start

June 1, 2023

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

DE(1)