Cytokine Adsorption in Acute-on-chronic Liver Failure

NCT05019352 | Unknown

• 1 other identifier: CYTOHEP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The CYTOHEP study is a prospective, randomized, single center, open-label, controlled intervention trial to assess the benefit of extracorporeal hemoadsorption using the CytoSorb device in patients with acute-on-chronic liver failure. The primary goal for this trial is to assess whether the CytoSorb device used in addition to continuous renal replacement therapy (CRRT) will be able to significantly reduce bilirubin in the patient blood as compared to the control group treated with CRRT alone (i.e., without extracorporeal hemoadsorption). The rationale for this study is based on considerations about the role of systemic inflammation in acute decompensation of liver cirrhosis and ACLF, in-vitro data of the effectiveness CytoSorb for the removal of molecules with a pathophysiological role in acute-on-chronic liver failure, and recent reports on the successful use of extracorporeal hemoadsorption in combination with CRRT in critically ill patients with acute liver dysfunction.

Conditions

Acute-On-Chronic Liver Failure; Renal Failure

Keywords

cytokine adsorption; renal replacement therapy; interleukins; cytokines

Outcome Measures

Primary Outcomes (1)

• Serum bilirubin

  Serum bilirubin after 72 hours

  72 hours

Secondary Outcomes (14)

• Survival time

  30 days

• Interleukin-6

  72 hours

• Liver function parameters

  72 hours

• Blood lactate

  72 hours

• CLIF-SOFA-score

  72 hours

Study Arms (3)

CRRT with cytokine adsorption

EXPERIMENTAL

Patients will be treated with CRRT and extracorporeal hemoadsorption for 72 hours

Device: CytoSorb cytokine adsorber; Device: CRRT

CRRT without cytokine adsorption

EXPERIMENTAL

Patients will be treated with CRRT without extracorporeal hemoadsorption for 72 hours

Device: CRRT

no CRRT, no cytokine adsorption

NO INTERVENTION

Patients will not receive CRRT, nor extracorporeal hemoadsorption. CRRT will only be initiated in case of severe electrolyte disorders or unmanageable fluid overload

Interventions

CytoSorb cytokine adsorber DEVICE

device for extracorporeal hemoadsorption

CRRT with cytokine adsorption

CRRT DEVICE

continuous renal replacement therapy

CRRT with cytokine adsorption; CRRT without cytokine adsorption

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (≥ 18 years) admitted to the University Medical Center Freiburg, Germany
• acute-on-chronic liver failure (ACLF) WITH acute kidney injury according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg/dl OR urine output ≤ 0.3 ml/kg/h for ≥ 24 hours OR anuria for ≥ 12 hours) AND serum bilirubin ≥ 5 mg/dl

You may not qualify if:

• known patient will against participation in the study or against the measures applied in the study
• no complete remission of malignancy including hepatocellular carcinoma within the past 12 months
• patients on the waiting list for liver transplant or the potential option for being listed for liver transplant within the next 6 months
• liver cirrhosis in patients after liver transplantation

Sponsors & Collaborators

• Dr. Alexander Supady: lead

Study Sites (1)

University Clinic Freiburg

Freiburg im Breisgau, 79108, Germany

RECRUITING

Related Publications (1)

• Sekandarzad A, Weber E, Prager EP, Graf E, Bettinger D, Wengenmayer T, Supady A. Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP)-a single center, open-label, three-arm, randomized, controlled intervention trial. Trials. 2022 Mar 18;23(1):222. doi: 10.1186/s13063-022-06139-6.

  PMID: 35303938 DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Renal Insufficiency

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexander Supady, MD, MPH

  University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Supady, MD, MPH

CONTACT

+49761270; alexander.supady@uniklinik-freiburg.de

Dominik Bettinger, MD

CONTACT

+49761270; dominik.bettinger@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label trial without masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oberarzt - Attending Physician

Model Details: In a prallel design participants will be randomly assigned to three different trial groups

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: October 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 30, 2023
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)