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

June 19, 2007
September 2, 2009
June 2007
August 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00488917 on ClinicalTrials.gov Archive Site
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Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA Study)
Sepsis, Endothelial Function, and Lipids in Critically Ill Patients With Liver Failure (the SELLIFA 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma, urine, ascites fluid.

Probability Sample

intensive care unit

  • Liver Diseases
  • Liver Cirrhosis
  • Sepsis
  • Critical Illness
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00488917
SELLIFA-01, B40320072194
Yes
Pierre-François Laterre, MD, Cliniques universitaires Saint-Luc, Université catholique de Louvain
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
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
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP