NCT01709565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

September 17, 2012

Last Update Submit

October 16, 2012

Conditions

SepsisLiver Failure

Keywords

SepsisLactic acidShockResuscitation

Outcome Measures

Primary Outcomes (1)

  • Lactate clearance

    \[(initial lactate - delayed lactate)/ initial lactate\] \*100%

    at 6-hour from the time of enrollment

Secondary Outcomes (1)

  • In-hospital mortality

    within the first 28-day after emergency department arrival

Study Arms (2)

No hepatic dysfunction

No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl

Hepatic dysfunction

Hepatic dysfunction, total plasma bilirubin \> 2.0 mg/dl

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

RECRUITING

Related Publications (7)

  • 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.

    PMID: 15286537BACKGROUND

  • 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.

    PMID: 9563714BACKGROUND

  • 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.

    PMID: 10102718BACKGROUND

  • 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.

    PMID: 16215376BACKGROUND

  • 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.

    PMID: 21970130BACKGROUND

  • 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.

    PMID: 11794169BACKGROUND

  • 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.

    PMID: 20179283BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Interleukin-1, Interleukin-6, Interleukin-10, TNF-alfa

MeSH Terms

Conditions

SepsisLiver FailureShock

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Ik Joon Jo, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ik Joon Jo, PhD

CONTACT

+82-2-3410-2053drjij@skku.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2012

First Posted

October 18, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

KR(1)