Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease

NCT04578301 | Recruiting

• 1 other identifier: PERSEVERE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational study to define precipitants and predictors of development of Acute-on-Chronic Liver Failure (ACLF) after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients. As well as identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.

Conditions

Liver Cirrhosis; Portal Hypertension; Surgery; Acute-On-Chronic Liver Failure; Non-Cirrhotic Portal Hypertension

Keywords

ACLF; Acute-On-Chronic Liver Failure; Liver Cirrhosis; Portal Hypertension; Surgery; Non-Cirrhotic Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Episodes of Acute-on-Chronic Liver Failure (ACLF)

  Development of ACLF after surgery

  90 days

Secondary Outcomes (2)

• 1-year mortality

  12 months

• Episodes of Acute Decompensation

  12 months

Other Outcomes (1)

• Intestinal Microbiota

  12 months

Study Arms (1)

Surgery

Patients with and without liver cirrhosis undergoing surgery.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Surgery

Eligibility Criteria

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

Study Population

Patients with and without liver cirrhosis and/or portal hypertension undergoing elective or emergency surgical intervention.

You may qualify if:

• Male or female adult (≥18 years) patient
• With or without liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and radiological signs)
• Or Non-cirrhotic portal hypertension
• Non-pregnant, non-lactating females
• Ability to understand the patient information and to personally sign and date the informed consent to participate in the study
• The patient is co-operative and available for the entire study
• Provided written informed consent
• Indication for surgical intervention

You may not qualify if:

• Pregnant or lactating females
• Patients undergoing surgery as form of palliative cancer therapy
• Presence or history of severe extra-hepatic diseases
• HIV-positive patients
• Previous liver or other transplantation
• Patients with acute or subacute liver failure without underlying cirrhosis
• Patients who decline to participate
• Physician´s denial (e.g. the investigator considers that the patient will not follow the protocol scheduled)

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool and tissue samples from surgical specimens

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Study Officials

• Michael Praktiknjo, MD

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

+4922828716375; michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

johannes.chang@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: September 22, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

DE (1)