Lactate Clearance According to the Presence of Hepatic Dysfunction

• Conditions: Sepsis; Liver Failure

• Registration Number: NCT01709565
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-17
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-16
• Last Update Submitted: 2012-10-16
• Study First Posted: 2012-10-18
• Last Update Posted: 2012-10-18
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

• Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival

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Exclusion Criteria

• Terminal malignancy or illness with a expected survival < 4 months
• Patients who previously signed "Do Not Resuscitate" or "Do Not Intubate" orders
• Patients who do not undergo the early goal-directed therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lactate clearance	at 6-hour from the time of enrollment	\[(initial lactate - delayed lactate)/ initial lactate\] \*100%

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	within the first 28-day after emergency department arrival

Trial Locations

Locations (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of