Liver DiseasesSELLIFANCT00488917
Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)
An observational study of Liver Diseases and Liver Cirrhosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of the study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Diseases, Liver Cirrhosis, Sepsis
- How many people
- 167 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care unit
Who may be able to join
- All consecutive patients with a diagnosis of chronic liver failure, acute on chronic liver failure, acute liver failure, or post-liver transplantation ;
- Adult patient aged 18 years or above, and less than 85 ;
- Admission to the ICU for an expected period of > 24 hours or elective admission for TIPSS placement ;
- Informed consent of the patient or nearest relative.
Who cannot join
- Age less than 18 years and more than 85 ;
- Pregnancy, including HELLP syndrome ;
- Active malignancy with metastases (localised hepatocellular carcinoma is not an exclusion criteria);
- Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localised hepatocellular carcinoma is not an exclusion criteria) ;
- Acquired immunodeficiency syndrome and antiretroviral therapy ;
- Refusal of the patient or nearest relative.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques Universitaires St Luc, Université Catholique de Louvain
Brussels, 1200
About this study
The purpose of the study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism.
Read the detailed description
Early diagnosis of sepsis may be difficult in patients with severe liver failure in the absence of usual warning clinical signs. Furthermore, routine laboratory tests like blood leucocyte count and serum c-reactive protein may be misleading in most of these patients. A great interest is taken in the identification of sepsis biomarkers or sepsis-induced alterations in the inflammation cascade, whose expression is independent of liver function. Determination of such a biomarker may be a useful tool for the early diagnosis of sepsis and may have a prognostic significance in patients with liver failure.
Septic complications in patients with liver failure may induce a disruption of liver microcirculation, which is regulated by several factors acting on endothelial and liver stellate cells. Furthermore, generation of reactive oxygen species results in an oxidative stress on lipids, proteins, and DNA. Lipid peroxidation may contribute to further hepatocellular injury and activation of systemic inflammation cascade. Both endothelial dysfunction and alterations in lipid metabolism may have a role in the prognosis of liver disease and its complications.
The purpose of this prospective observational study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism. In addition, the porto-systemic gradient of these parameters will be determined in patients planned for a transjugular intra-hepatic porto-systemic shunt (TIPSS).
An overall number of 120 patients will be enrolled. According to the mode of presentation, the planned number of patients in the different study groups will be as follow : 70 patients with chronic liver failure and acute on chronic liver failure; 20 patients with acute liver failure ; 30 patients post-liver transplantation.
- Conditions
- Liver Diseases, Liver Cirrhosis, Sepsis, Critical Illness
- Keywords
- Liver cirrhosis, acute liver failure, liver transplantation, sepsis, infection, endothelium, lipids, diagnosis, prognosis
- Medical subject headings
- Liver Diseases, Liver Cirrhosis, Sepsis, Critical Illness, Liver Failure, Acute, Infections, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Investigators
- Pierre-François Laterre, MD, Study director, Cliniques Universitaires St Luc, Université Catholique de LouvainYvan Fleury, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488917
- Sponsor's protocol ID
- SELLIFA-01
- Other IDs
- B40320072194
- Acronym
- SELLIFA
- Status last verified
- Sep 2009
- First submitted
- 19 Jun 2007
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)
- ClinicalTrials.gov ID
- NCT00488917
- Acronym / sponsor ID
- SELLIFA / SELLIFA-01
- Conditions
- Liver Diseases, Liver Cirrhosis, Sepsis, Critical Illness
- Keywords
- Liver cirrhosis, acute liver failure, liver transplantation, sepsis, infection, endothelium, lipids, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Jun 2007 (estimated)
- 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.
The purpose of the study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism.
Detailed description
Early diagnosis of sepsis may be difficult in patients with severe liver failure in the absence of usual warning clinical signs. Furthermore, routine laboratory tests like blood leucocyte count and serum c-reactive protein may be misleading in most of these patients. A great interest is taken in the identification of sepsis biomarkers or sepsis-induced alterations in the inflammation cascade, whose expression is independent of liver function. Determination of such a biomarker may be a useful tool for the early diagnosis of sepsis and may have a prognostic significance in patients with liver failure.
Septic complications in patients with liver failure may induce a disruption of liver microcirculation, which is regulated by several factors acting on endothelial and liver stellate cells. Furthermore, generation of reactive oxygen species results in an oxidative stress on lipids, proteins, and DNA. Lipid peroxidation may contribute to further hepatocellular injury and activation of systemic inflammation cascade. Both endothelial dysfunction and alterations in lipid metabolism may have a role in the prognosis of liver disease and its complications.
The purpose of this prospective observational study is to determine the role of new biomarkers in the diagnosis of sepsis in critically-ill patients with liver failure and to correlate the prognosis of these patients with parameters of endothelial function and lipid metabolism. In addition, the porto-systemic gradient of these parameters will be determined in patients planned for a transjugular intra-hepatic porto-systemic shunt (TIPSS).
An overall number of 120 patients will be enrolled. According to the mode of presentation, the planned number of patients in the different study groups will be as follow : 70 patients with chronic liver failure and acute on chronic liver failure; 20 patients with acute liver failure ; 30 patients post-liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care unit
Key inclusion criteria (4 listed)
- All consecutive patients with a diagnosis of chronic liver failure, acute on chronic liver failure, acute liver failure, or post-liver transplantation ;
- Adult patient aged 18 years or above, and less than 85 ;
- Admission to the ICU for an expected period of > 24 hours or elective admission for TIPSS placement ;
- Informed consent of the patient or nearest relative.
Key exclusion criteria (6 listed)
- Age less than 18 years and more than 85 ;
- Pregnancy, including HELLP syndrome ;
- Active malignancy with metastases (localised hepatocellular carcinoma is not an exclusion criteria);
- Systemic chemotherapy in the last 4 weeks (trans-arterial chemo-embolisation for localised hepatocellular carcinoma is not an exclusion criteria) ;
- Acquired immunodeficiency syndrome and antiretroviral therapy ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
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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. This study is not recruiting at the moment.
Pierre-François Laterre, MD study director
Cliniques Universitaires St Luc, Université Catholique de Louvain
Yvan Fleury, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Diseases and Liver Cirrhosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 3 Sep 2009. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 3 Sep 2009.