Predicting liver failure after surgery in patients with chronic liver disease
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
This study is trying to find out what causes liver failure after surgery in people with chronic liver disease to help doctors better predict risks for their patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn Academic / other |
| Locations | 1 site (Bonn) |
| Trial ID | NCT04578301 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the precipitants and predictors of Acute-on-Chronic Liver Failure (ACLF) following surgical interventions in patients with chronic liver disease. By investigating clinical markers and molecular mechanisms associated with ACLF, the study seeks to develop a risk stratification tool for elective surgeries in cirrhotic patients. The research will involve prospective data collection from patients undergoing surgery, with a focus on understanding the underlying causes of ACLF and its relationship with surgical procedures.
Who should consider this trial
Good fit: Ideal candidates include adult patients with or without liver cirrhosis who require surgical intervention.
Not a fit: Patients undergoing surgery for palliative cancer therapy or those with acute liver failure without underlying cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with chronic liver disease undergoing surgery.
How similar studies have performed: While the study addresses a relatively novel area, previous research has indicated the importance of identifying risk factors for ACLF, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Bonn
- University Hospital Bonn — Bonn, Germany (Recruiting)
Study contacts
- Principal investigator: Michael Praktiknjo, MD — University Hospital, Bonn
- Study coordinator: Michael Praktiknjo, MD
- Email: michael.praktiknjo@ukbonn.de
- Phone: +4922828716375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.