Lactate Clearance According to the Presence of Hepatic Dysfunction

This study is currently recruiting participants.

Verified October 2012 by Samsung Medical Center

Sponsor:

Information provided by (Responsible Party):

Jo, Ik Joon, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01709565

First received: September 17, 2012

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Purpose

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.

Condition
Sepsis Liver Failure

Study Type:	Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Lactate clearance [ Time Frame: at 6-hour from the time of enrollment ] [ Designated as safety issue: No ]
[(initial lactate − delayed lactate)/ initial lactate] *100%

Secondary Outcome Measures:

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

Estimated Enrollment:	245
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)

Groups/Cohorts
No hepatic dysfunction No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl
Hepatic dysfunction Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients presenting to the emergency department and meeting criteria for severe sepsis or septic shock at Samsung Medical Center (a 1,960 bed, university-affiliated, tertiary referral hospital in Seoul, South Korea)

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709565

Contacts

Contact: Ik Joon Jo, PhD

+82-2-3410-2053

drjij@skku.edu

Locations

Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine	Recruiting
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Ik Joon Jo, PhD

Samsung Medical Center

More Information

Publications:

Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, Tomlanovich MC. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004 Aug;32(8):1637-42.

Levraut J, Ciebiera JP, Chave S, Rabary O, Jambou P, Carles M, Grimaud D. Mild hyperlactatemia in stable septic patients is due to impaired lactate clearance rather than overproduction. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1021-6.

De Jonghe B, Cheval C, Misset B, Timsit JF, Garrouste M, Montuclard L, Carlet J. Relationship between blood lactate and early hepatic dysfunction in acute circulatory failure. J Crit Care. 1999 Mar;14(1):7-11.

Revelly JP, Tappy L, Martinez A, Bollmann M, Cayeux MC, Berger MM, Chioléro RL. Lactate and glucose metabolism in severe sepsis and cardiogenic shock. Crit Care Med. 2005 Oct;33(10):2235-40.

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77.

Responsible Party:	Jo, Ik Joon, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01709565 History of Changes
Other Study ID Numbers:	SamsungMC
Study First Received:	September 17, 2012
Last Updated:	October 16, 2012
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Sepsis
Lactic acid
Shock
Resuscitation

Additional relevant MeSH terms:

Sepsis
Toxemia
Liver Failure
Liver Diseases
Infection

Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Hepatic Insufficiency
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013

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