<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/NCT01697410</url>
  </required_header>
  <id_info>
    <org_study_id>2012A080204018;2007015</org_study_id>
    <nct_id>NCT01697410</nct_id>
  </id_info>
  <brief_title>Continuos Terlipressin Infusion in Septic Shock</brief_title>
  <official_title>A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Province, Department of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing 302 Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Changzheng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Bengbu Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hainan People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Science Center of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First People's Hospital of Foshan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZhuHai Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of terlipressin for treating septic&#xD;
      shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Septic shock is the most common cause of death in intensive care units and has a mortality&#xD;
      rate of 40 to 60%.Vasopressin is commonly used as an adjunct to catecholamines to support&#xD;
      blood pressure in refractory septic shock.Recently small sample clinical study suggest that&#xD;
      Terlipressin,a vasopressin analogues, was effective in reversing sepsis-induced arterial&#xD;
      hypotension and in reducing norepinephrine requirements.But its effect on mortality is&#xD;
      unknown.Invesgators hypothesized that Terlipressin as compared with norepinephrine would&#xD;
      decrease mortality among patients with septic shock.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>28-day Mortality</measure>
    <time_frame>28-days</time_frame>
    <description>The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SOFA score</measure>
    <time_frame>7 days</time_frame>
    <description>SOFA score was measured on day0-7 after the start of the infusion in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>days alive and free of vasopressor</measure>
    <time_frame>during the first 28 days after the start of the infusion</time_frame>
    <description>Days of vasopressor were recorded after the start of the infusion in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days after the start of the infusion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>terlipressin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terlipressin</intervention_name>
    <description>continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure</description>
    <arm_group_label>terlipressin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure</description>
    <arm_group_label>norepinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Septic shock was defined by the presence of two or more diagnostic criteria for the&#xD;
             systemic inflammatory responsesyndrome, proven or suspected infection, and hypotension&#xD;
             (exclusion of hypertention other than sepsis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  organ transplantation;&#xD;
&#xD;
          -  pregancy or breast-feeding;&#xD;
&#xD;
          -  malignancy or other irreversible disease or condition for which has a poor prognosis;&#xD;
&#xD;
          -  acute coronary syndrome;&#xD;
&#xD;
          -  chronic heart failure(NYHA III or IV)/cardiogenic shock;&#xD;
&#xD;
          -  acute mesenteric ischemia;&#xD;
&#xD;
          -  greater than 48 hours had elapsed since the patient met entry criteria;&#xD;
&#xD;
          -  estimation of incomplite treament due to financial problem;&#xD;
&#xD;
          -  use of terlipressin for blood pressure support before entry;&#xD;
&#xD;
          -  Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;&#xD;
&#xD;
          -  registration of other clinical trial which will affect the outcome of the current&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guan XiangDong, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>first affiliated hospital SunYetSen university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>liu ZiMeng, M.D</last_name>
    <role>Study Director</role>
    <affiliation>first affiliated hospital ,SunYetSen university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Si Xiang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>first affiliated hospital ,SunYetSen university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chen Juan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>first affiliated hospital ,SunYetSen university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guan Xiangdong, M.D.</last_name>
    <phone>862087755766-8456</phone>
    <email>carlg@163.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liu Zimeng, M.D.</last_name>
    <phone>862087755766-8454</phone>
    <email>sumslzm@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Surgical intensive care unit, 1st affiliated hospital of Sun Yat-sen university</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guan Xiangdong, M.D.</last_name>
      <phone>862087555766-8456</phone>
      <email>carlg@163.net</email>
    </contact>
    <investigator>
      <last_name>Guan Xiangdon, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 25, 2014</last_update_submitted>
  <last_update_submitted_qc>December 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Guan XiangDong</investigator_full_name>
    <investigator_title>director of surgical intensive care unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Terlipressin</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_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/NCT01697410
org study id: 2012A080204018;2007015
nct id: NCT01697410
lead sponsor: 
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has dmc: Yes
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic
      shock.
Septic shock is the most common cause of death in intensive care units and has a mortality
      rate of 40 to 60%.Vasopressin is commonly used as an adjunct to catecholamines to support
      blood pressure in refractory septic shock.Recently small sample clinical study suggest that
      Terlipressin,a vasopressin analogues, was effective in reversing sepsis-induced arterial
      hypotension and in reducing norepinephrine requirements.But its effect on mortality is
      unknown.Invesgators hypothesized that Terlipressin as compared with norepinephrine would
      decrease mortality among patients with septic shock.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 28-day Mortality
time frame: 28-days
description: The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion
measure: SOFA score
time frame: 7 days
description: SOFA score was measured on day0-7 after the start of the infusion in both groups
measure: days alive and free of vasopressor
time frame: during the first 28 days after the start of the infusion
description: Days of vasopressor were recorded after the start of the infusion in both groups.
measure: 90-day mortality
time frame: 90 days after the start of the infusion
arm group label: terlipressin
arm group type: Experimental
arm group label: norepinephrine
arm group type: Active Comparator
intervention type: Drug
intervention name: Terlipressin
description: continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
arm group label: terlipressin
intervention type: Drug
intervention name: Norepinephrine
description: continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
arm group label: norepinephrine
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Guan XiangDong, doctor
role: Study Chair
affiliation: first affiliated hospital SunYetSen university
last name: liu ZiMeng, M.D
role: Study Director
affiliation: first affiliated hospital ,SunYetSen university
last name: Si Xiang, M.D.
role: Principal Investigator
affiliation: first affiliated hospital ,SunYetSen university
last name: Chen Juan, M.D.
role: Principal Investigator
affiliation: first affiliated hospital ,SunYetSen university
last name: Guan Xiangdong, M.D.
phone: 862087755766-8456
email: carlg@163.net
last name: Liu Zimeng, M.D.
phone: 862087755766-8454
email: sumslzm@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Guan XiangDong
investigator title: director of surgical intensive care unit
mesh term: Shock, Septic
mesh term: Shock
mesh term: Terlipressin
mesh term: Norepinephrine