Lactate Clearance According to the Presence of Hepatic Dysfunction

Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by 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 Overview

• Status: Unknown
• Conditions: Liver Failure; Sepsis

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.

• Study Type: Observational
• Enrollment (Anticipated): 245

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No hepatic dysfunction; No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl
Hepatic dysfunction; Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactate clearance	[(initial lactate - delayed lactate)/ initial lactate] *100%	at 6-hour from the time of enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
In-hospital mortality	within the first 28-day after emergency department arrival

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Ik Joon Jo, PhD, Samsung Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2012
• Last Update Submitted That Met QC Criteria: October 16, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Shock; Sepsis; Resuscitation; Lactic acid
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Liver Diseases; Sepsis; Liver Failure
• Other Study ID Numbers: SamsungMC