Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00488917
First received: June 19, 2007
Last updated: September 2, 2009
Last verified: September 2009
  Purpose

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.


Condition
Liver Diseases
Liver Cirrhosis
Sepsis
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Biospecimen Retention:   Samples Without DNA

plasma, urine, ascites fluid.


Enrollment: 167
Study Start Date: June 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

intensive care unit

Criteria

Inclusion Criteria :

  • 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.

Exclusion Criteria :

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488917

Locations
Belgium
Cliniques Universitaires St Luc, Université Catholique de Louvain
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Director: Pierre-François Laterre, MD Cliniques Universitaires St Luc, Université Catholique de Louvain
Principal Investigator: Yvan Fleury, MD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Pierre-François Laterre, MD, Cliniques universitaires Saint-Luc, Université catholique de Louvain
ClinicalTrials.gov Identifier: NCT00488917     History of Changes
Other Study ID Numbers: SELLIFA-01, B40320072194
Study First Received: June 19, 2007
Last Updated: September 2, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Liver cirrhosis
acute liver failure
liver transplantation
sepsis, infection
endothelium
lipids
diagnosis
prognosis

Additional relevant MeSH terms:
Critical Illness
Liver Cirrhosis
Fibrosis
Liver Diseases
Sepsis
Toxemia
Liver Failure
Disease Attributes
Pathologic Processes
Digestive System Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hepatic Insufficiency

ClinicalTrials.gov processed this record on July 29, 2014