Liver CirrhosisPERSEVERENCT04578301
Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
An observational study of Liver Cirrhosis and Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension, Surgery
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 22 Sep 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without liver cirrhosis and/or portal hypertension undergoing elective or emergency surgical intervention.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johannes Chang, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn
Michael Praktiknjo, MD, +49228 28715770, michael.praktiknjo@ukbonn.de
Johannes Chang, MD, +49228 28715770, johannes.chang@ukbonn.de
About this study
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.
Read the detailed description
Background: Acute-on-chronic liver failure (ACLF) is a recently discovered syndrome, which is understood as an acute deterioration of decompen-sated liver cirrhosis. It is defined on the basis of organ failure(s) and associated with high short-term mortality. ACLF is caused by a precipi-tating event that results in excessive systemic inflammation. ACLF is mostly precipitated and associated with bacterial infections but 40-50% of the underlying cause is unclear. Surgery, with or without liver involvement, has been defined as such a precipitating event. It is long known, that surgery in liver cirrhotic patients, depending on stage of cirrhosis as well as on type of surgery, bears a great risk but is still in-evitable in some cases. Child-Turquotte Score has been used for risk stratification of postoperative mortality. The development and out-come of ACLF after surgical interventions have not been characterized yet. In addition, underlying causes as well as molecular mechanism leading to ACLF after surgical intervention have not been identified. The aim of this trial is to further prospectively investigate patients with cirrhosis undergoing surgery to identify clinical markers and molecular mechanisms involved in development of ACLF.
Objectives: Defining precipitants and predictors of development of ACLF after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients.
Identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.
Study design: Prospective, observational study. Patients will be screened according inclusion/exclusion criteria. After informed consent sample processing will be possible from max. 1 week before scheduled surgery.
Primary endpoints: Development of ACLF within 28 and 90 days after visceral or non-visceral surgery in patients with portal hypertension (liver cirrhosis and idiopathic non-cirrhotic portal hypertension)
Secondary endpoints:
- Mortality at 1 month, 3 months and 1 year. Following endpoints will be evaluated: " Time to death and mortality (overall and surgery-related) " Time to and rate of unplanned rehospitalizations after surgery " Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis " Postsurgical acute hepatic decompensation and ACLF
- To assess the changes in the intestinal microbiota in both groups and evaluate its effect on the primary endpoint.
- To assess the potential socioeconomic impact.
- Conditions
- Liver Cirrhosis, Portal Hypertension, Surgery, Acute-On-Chronic Liver Failure, Non-Cirrhotic Portal Hypertension
- Being tested
- No Intervention
- Keywords
- ACLF, Acute-On-Chronic Liver Failure, Liver Cirrhosis, Portal Hypertension, Surgery, Non-Cirrhotic Portal Hypertension
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Patients with and without liver cirrhosis undergoing surgery. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Acute-on-Chronic Liver Failure (ACLF)
Development of ACLF after surgery
Measured: 90 days
Secondary outcomes (2)
1-year mortality
Death after surgery
Measured: 12 months
Episodes of Acute Decompensation
Acute hepatic Decompensation after Surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start22 Sep 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Praktiknjo, University Hospital, Bonn
- Investigators
- Michael Praktiknjo, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578301
- Sponsor's protocol ID
- PERSEVERE
- Acronym
- PERSEVERE
- Status last verified
- May 2022
- First submitted
- 22 Sep 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04578301
- Acronym / sponsor ID
- PERSEVERE / PERSEVERE
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Acute-on-chronic liver failure (ACLF) is a recently discovered syndrome, which is understood as an acute deterioration of decompen-sated liver cirrhosis. It is defined on the basis of organ failure(s) and associated with high short-term mortality. ACLF is caused by a precipi-tating event that results in excessive systemic inflammation. ACLF is mostly precipitated and associated with bacterial infections but 40-50% of the underlying cause is unclear. Surgery, with or without liver involvement, has been defined as such a precipitating event. It is long known, that surgery in liver cirrhotic patients, depending on stage of cirrhosis as well as on type of surgery, bears a great risk but is still in-evitable in some cases. Child-Turquotte Score has been used for risk stratification of postoperative mortality. The development and out-come of ACLF after surgical interventions have not been characterized yet. In addition, underlying causes as well as molecular mechanism leading to ACLF after surgical intervention have not been identified. The aim of this trial is to further prospectively investigate patients with cirrhosis undergoing surgery to identify clinical markers and molecular mechanisms involved in development of ACLF.
Objectives: Defining precipitants and predictors of development of ACLF after surgical interventions, allowing to develop a risk stratification for elective procedures in cirrhotic patients.
Identifying molecular mechanisms of post-interventional ACLF and thus preparing the ground for development of new therapeutic approaches.
Study design: Prospective, observational study. Patients will be screened according inclusion/exclusion criteria. After informed consent sample processing will be possible from max. 1 week before scheduled surgery.
Primary endpoints: Development of ACLF within 28 and 90 days after visceral or non-visceral surgery in patients with portal hypertension (liver cirrhosis and idiopathic non-cirrhotic portal hypertension)
Secondary endpoints:
- Mortality at 1 month, 3 months and 1 year. Following endpoints will be evaluated: " Time to death and mortality (overall and surgery-related) " Time to and rate of unplanned rehospitalizations after surgery " Any Infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis " Postsurgical acute hepatic decompensation and ACLF
- To assess the changes in the intestinal microbiota in both groups and evaluate its effect on the primary endpoint.
- To assess the potential socioeconomic impact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Other: No InterventionPatients with and without liver cirrhosis undergoing surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without liver cirrhosis and/or portal hypertension undergoing elective or emergency surgical intervention.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | Surgery |
Primary outcome
Episodes of Acute-on-Chronic Liver Failure (ACLF)
Time frame: 90 days
Development of ACLF after surgery
2 secondary outcomes
1-year mortality
Time frame: 12 months
Episodes of Acute Decompensation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Chang, MD contact
Michael Praktiknjo, MD principal investigator
University Hospital, Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Praktiknjo, MD (+4922828716375, michael.praktiknjo@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of Acute-on-Chronic Liver Failure (ACLF) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.