Lactate Clearance According to the Presence of Hepatic Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Liver Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014