<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01709565</url>
  </required_header>
  <id_info>
    <org_study_id>SamsungMC</org_study_id>
    <nct_id>NCT01709565</nct_id>
  </id_info>
  <brief_title>Lactate Clearance According to the Presence of Hepatic Dysfunction</brief_title>
  <official_title>Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare lactate clearance in patients with severe sepsis and&#xD;
      septic shock according to the presence of hepatic dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lactate clearance is well known to be associated with mortality in patients with severe&#xD;
      sepsis and septic shock. To normalize lactate levels is one of important goals of early&#xD;
      resuscitation of sepsis patients.&#xD;
&#xD;
      Lactate clearance can be changed by various factors including patient characteristics,&#xD;
      severity of shock, and treatment. In particular, hepatic dysfunction might impair the&#xD;
      clearance of lactate because liver is a principal organ for lactate metabolism. However, an&#xD;
      association between lactate clearance and hepatic failure has not been evaluated during&#xD;
      initial resuscitation of patients with severe sepsis and septic shock. The primary goal of&#xD;
      this study is to compare lactate clearance in patients with severe sepsis and septic shock&#xD;
      according to the presence of hepatic dysfunction. The secondary goal is to evaluate if&#xD;
      lactate clearance is associated with mortality even in patients with hepatic dysfunction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Lactate clearance</measure>
    <time_frame>at 6-hour from the time of enrollment</time_frame>
    <description>[(initial lactate - delayed lactate)/ initial lactate] *100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>within the first 28-day after emergency department arrival</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">245</enrollment>
  <condition>Sepsis</condition>
  <condition>Liver Failure</condition>
  <arm_group>
    <arm_group_label>No hepatic dysfunction</arm_group_label>
    <description>No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hepatic dysfunction</arm_group_label>
    <description>Hepatic dysfunction, total plasma bilirubin &gt; 2.0 mg/dl</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Interleukin-1, Interleukin-6, Interleukin-10, TNF-alfa&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the emergency department and meeting criteria for severe sepsis or&#xD;
        septic shock at Samsung Medical Center (a 1,960 bed, university-affiliated, tertiary&#xD;
        referral hospital in Seoul, South Korea)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who presented with septic shock or severe sepsis within 6 hours after&#xD;
             emergency department arrival&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal malignancy or illness with a expected survival &lt; 4 months&#xD;
&#xD;
          -  Patients who previously signed &quot;Do Not Resuscitate&quot; or &quot;Do Not Intubate&quot; orders&#xD;
&#xD;
          -  Patients who do not undergo the early goal-directed therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ik Joon Jo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ik Joon Jo, PhD</last_name>
    <phone>+82-2-3410-2053</phone>
    <email>drjij@skku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center, Sungkyunkwan University School of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <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>
    <PMID>15286537</PMID>
  </reference>
  <reference>
    <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>
    <PMID>9563714</PMID>
  </reference>
  <reference>
    <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>
    <PMID>10102718</PMID>
  </reference>
  <reference>
    <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>
    <PMID>16215376</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21970130</PMID>
  </reference>
  <reference>
    <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>
    <PMID>11794169</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20179283</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jo, Ik Joon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Lactic acid</keyword>
  <keyword>Shock</keyword>
  <keyword>Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01709565
org study id: SamsungMC
nct id: NCT01709565
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Lactate clearance
time frame: at 6-hour from the time of enrollment
description: [(initial lactate - delayed lactate)/ initial lactate] *100%
measure: In-hospital mortality
time frame: within the first 28-day after emergency department arrival
arm group label: No hepatic dysfunction
description: No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl
arm group label: Hepatic dysfunction
description: Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl
Interleukin-1, Interleukin-6, Interleukin-10, TNF-alfa
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ik Joon Jo, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Ik Joon Jo, PhD
phone: +82-2-3410-2053
email: drjij@skku.edu
facility: 
status: Recruiting
country: Korea, Republic of
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.
PMID: 15286537
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.
PMID: 9563714
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.
PMID: 10102718
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.
PMID: 16215376
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.
PMID: 21970130
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.
PMID: 11794169
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.
PMID: 20179283
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jo, Ik Joon
investigator title: Associate Professor
mesh term: Sepsis
mesh term: Liver Failure