Lactate Clearance According to the Presence of Hepatic Dysfunction

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01709565
• Other study ID #: SamsungMC
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2012
• Last updated: October 16, 2012
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2012
• Source: Samsung Medical Center
• Contact: Ik Joon Jo, PhD
• Phone: +82-2-3410-2053
• Email: drjij[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 245
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Failure
• Sepsis

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate clearance	[(initial lactate - delayed lactate)/ initial lactate] *100%	at 6-hour from the time of enrollment	No
Secondary	In-hospital mortality		within the first 28-day after emergency department arrival	No