Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488917
Status:
COMPLETED
Last Update Posted:
2009-09-03
First Post:
2007-06-19
Brief Title:
Sepsis Endothelial Function and Lipids in Critically Ill Patients With Liver Failure the SELLIFA Study
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
Sepsis Endothelial Function and Lipids in Critically Ill Patients With Liver Failure the SELLIFA Study
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SELLIFA
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B40320072194 | None | None | None |