Clinical trial NCT01709565: Lactate Clearance According to the Presence of Hepatic Dysfunction
Official title: Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Liver Failure
Keywords: Sepsis
Lactic acid
Shock
Resuscitation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 245
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Eligibility 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

Primary outcomes:
measure: Lactate clearance
timeFrame: at 6-hour from the time of enrollment
Secondary outcomes:
measure: In-hospital mortality
timeFrame: within the first 28-day after emergency department arrival
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Ik Joon Jo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.ccm.0000132904.35713.a7.
citation: 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. doi: 10.1164/ajrccm.157.4.9705037.
citation: 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. doi: 10.1016/s0883-9441(99)90002-3.
citation: Revelly JP, Tappy L, Martinez A, Bollmann M, Cayeux MC, Berger MM, Chiolero RL. Lactate and glucose metabolism in severe sepsis and cardiogenic shock. Crit Care Med. 2005 Oct;33(10):2235-40. doi: 10.1097/01.ccm.0000181525.99295.8f.
citation: Kang YR, Um SW, Koh WJ, Suh GY, Chung MP, Kim H, Kwon OJ, Jeon K. Initial lactate level and mortality in septic shock patients with hepatic dysfunction. Anaesth Intensive Care. 2011 Sep;39(5):862-7. doi: 10.1177/0310057X1103900510.
citation: 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. doi: 10.1056/NEJMoa010307.
citation: Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.