Lactate Clearance According to the Presence of Hepatic Dysfunction
The purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction|
- Lactate clearance [ Time Frame: at 6-hour from the time of enrollment ] [ Designated as safety issue: No ][(initial lactate − delayed lactate)/ initial lactate] *100%
- In-hospital mortality [ Time Frame: within the first 28-day after emergency department arrival ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Interleukin-1, Interleukin-6, Interleukin-10, TNF-alfa
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
No hepatic dysfunction
No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl
Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl
Lactate clearance is well known to be associated with mortality in patients with severe sepsis and septic shock. To normalize lactate levels is one of important goals of early resuscitation of sepsis patients.
Lactate clearance can be changed by various factors including patient characteristics, severity of shock, and treatment. In particular, hepatic dysfunction might impair the clearance of lactate because liver is a principal organ for lactate metabolism. However, an association between lactate clearance and hepatic failure has not been evaluated during initial resuscitation of patients with severe sepsis and septic shock. The primary goal of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. The secondary goal is to evaluate if lactate clearance is associated with mortality even in patients with hepatic dysfunction.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709565
|Contact: Ik Joon Jo, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center, Sungkyunkwan University School of Medicine||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Ik Joon Jo, PhD||Samsung Medical Center|