Lactate Clearance According to the Presence of Hepatic Dysfunction
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ClinicalTrials.gov Identifier: NCT01709565 |
Recruitment Status
: Unknown
Verified October 2012 by Jo, Ik Joon, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted
: October 18, 2012
Last Update Posted
: October 18, 2012
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Condition or disease |
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Sepsis Liver Failure |
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.
Study Type : | Observational |
Estimated Enrollment : | 245 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | June 2014 |
Estimated Study Completion Date : | June 2014 |
Group/Cohort |
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No hepatic dysfunction
No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl
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Hepatic dysfunction
Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl
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- Lactate clearance [ Time Frame: at 6-hour from the time of enrollment ][(initial lactate − delayed lactate)/ initial lactate] *100%
- In-hospital mortality [ Time Frame: within the first 28-day after emergency department arrival ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709565
Contact: Ik Joon Jo, PhD | +82-2-3410-2053 | drjij@skku.edu |
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 |
Publications:
Responsible Party: | Jo, Ik Joon, Associate Professor, Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT01709565 History of Changes |
Other Study ID Numbers: |
SamsungMC |
First Posted: | October 18, 2012 Key Record Dates |
Last Update Posted: | October 18, 2012 |
Last Verified: | October 2012 |
Keywords provided by Jo, Ik Joon, Samsung Medical Center:
Sepsis Lactic acid Shock Resuscitation |
Additional relevant MeSH terms:
Sepsis Liver Failure Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Hepatic Insufficiency Liver Diseases Digestive System Diseases |