<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/NCT01681238</url>
  </required_header>
  <id_info>
    <org_study_id>GZZD-025</org_study_id>
    <nct_id>NCT01681238</nct_id>
  </id_info>
  <brief_title>Goal-directed Therapy in High-risk Surgery</brief_title>
  <official_title>A Randomized Study of Goal-directed Therapy in the Elderly High-risk Patients Undergoing Total Hip Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou First People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is growing evidence that the risk of postoperative complications can be decreased by&#xD;
      optimizing the amount and type of infusion fluids given during surgery, steered by&#xD;
      goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk&#xD;
      patients. This study is undertaken subsequently to test the hypothesis that the&#xD;
      intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor,&#xD;
      can partially prevented postoperative complications and shorten hospital stay in the elderly&#xD;
      high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central&#xD;
      venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with&#xD;
      ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during&#xD;
      the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences,&#xD;
      Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured&#xD;
      and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic&#xD;
      (body temperature &gt; 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate&#xD;
      solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when&#xD;
      the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to&#xD;
      different protocol group according to the study arm to which the patient&#xD;
      allocated.Postoperative care and discharge criteria were predefined using the hospital care&#xD;
      map and protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of postoperative hospital stay</measure>
    <time_frame>28 days</time_frame>
    <description>days from end of surgery to hospital discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative complications and mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Major complications: Infection , Major cardiovascular complications , Pulmonary Embolism, Renal Failure, Anaemia requiring blood transfusion in the presence of shock.&#xD;
Minor complications: Hypotension (systolic blood pressure &lt; 90 mmHg) requiring fluid boluses, Uncomplicated infections (not requiring intra-venous antibiotic therapy and with no signs of sepsis, i.e. uncomplicated urinary tract infections), Anemia requiring blood transfusions in the absence of shock.&#xD;
PONV: Postoperative Nausea and Vomiting&#xD;
delirium and postoperative cognitive dysfunction&#xD;
mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>information of hemodynamic and ScvO2 ,types and volumes of all fluids administered</measure>
    <time_frame>24 hours after operation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Perioperative/Postoperative Complications</condition>
  <condition>Hypovolemia</condition>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>Protocol group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using standard hemodynamic therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protocol group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using goal-directed therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Protocol group 2</intervention_name>
    <description>ensure SpO2≥ 92%, MAP 65-100 mmHg, HR &lt;100 bpm, Hb&gt; 8mg/dL and temperature ≥ 36℃, the patients were then administrated a 200 ml colloid as a fluid challenge. The fluid challenge repeat until the SV failed to increase by a factor of 10%. If at this stage the DO2I can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 120 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL</description>
    <arm_group_label>Protocol group 2</arm_group_label>
    <other_name>goal-directed therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Protocol group 1</intervention_name>
    <description>The goal of this protocol is to ensure MAP&gt; 65 mmHg, CVP 8-12 cmH2O. If meet the above requirements, do nothing, re-evaluate after 5min. If CVP &lt;8 cmH2O, the patient will receive an additional 200ml colloid .If MAP beyond the scope of 65-100 mmHg, vasoactive agents will be administrated until achieve the goal. If 25mL/kg colloid given before goal is achieved, fluid challenges will then be performed with 200mL boluses of Ringer's lactate solution. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL</description>
    <arm_group_label>Protocol group 1</arm_group_label>
    <other_name>conventional fluid management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Adult patients scheduled for total hip replacement at this institution.&#xD;
&#xD;
          -  2. American Society of Anaesthesiologists (ASA) physical status of III or VI.&#xD;
&#xD;
          -  3. Two or more risk factors according to risk index of Lee .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Age under 70years old&#xD;
&#xD;
          -  2. idiopathic coagulopathy: with warfarin or heparin&#xD;
&#xD;
          -  3. systemic or local infection&#xD;
&#xD;
          -  4. unable to cooperate&#xD;
&#xD;
          -  5. spinal trauma or severe low back pain history&#xD;
&#xD;
          -  6. patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiangcai Ruan, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou First Municipal People's Hospital,Guangzhou Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangzhou First Municipal People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.</citation>
    <PMID>12357146</PMID>
  </reference>
  <reference>
    <citation>Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008 Mar;106(3):867-72, table of contents. doi: 10.1213/ane.0b013e318161964d.</citation>
    <PMID>18292432</PMID>
  </reference>
  <reference>
    <citation>Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.</citation>
    <PMID>21624138</PMID>
  </reference>
  <reference>
    <citation>Lees N, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy in high risk surgical patients. Crit Care. 2009;13(5):231. doi: 10.1186/cc8039. Epub 2009 Oct 26.</citation>
    <PMID>19863764</PMID>
  </reference>
  <reference>
    <citation>Moore JM. Continuous spinal anesthesia. Am J Ther. 2009 Jul-Aug;16(4):289-94. doi: 10.1097/MJT.0b013e3181729d2a.</citation>
    <PMID>19546804</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 5, 2012</last_update_submitted>
  <last_update_submitted_qc>September 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou First People's Hospital</investigator_affiliation>
    <investigator_full_name>Xiangcai Ruan</investigator_full_name>
    <investigator_title>Professor, Vice Chair</investigator_title>
  </responsible_party>
  <keyword>perioperative fluid optimization</keyword>
  <keyword>goal-directed therapy</keyword>
  <keyword>elderly</keyword>
  <keyword>high-risk surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Hypovolemia</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/NCT01681238
org study id: GZZD-025
nct id: NCT01681238
lead sponsor: 
has dmc: Yes
There is growing evidence that the risk of postoperative complications can be decreased by
      optimizing the amount and type of infusion fluids given during surgery, steered by
      goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk
      patients. This study is undertaken subsequently to test the hypothesis that the
      intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor,
      can partially prevented postoperative complications and shorten hospital stay in the elderly
      high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .
After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central
      venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with
      ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during
      the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences,
      Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured
      and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic
      (body temperature > 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate
      solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when
      the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to
      different protocol group according to the study arm to which the patient
      allocated.Postoperative care and discharge criteria were predefined using the hospital care
      map and protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: length of postoperative hospital stay
time frame: 28 days
description: days from end of surgery to hospital discharge.
measure: postoperative complications and mortality
time frame: 28 days
description: Major complications: Infection , Major cardiovascular complications , Pulmonary Embolism, Renal Failure, Anaemia requiring blood transfusion in the presence of shock.
Minor complications: Hypotension (systolic blood pressure < 90 mmHg) requiring fluid boluses, Uncomplicated infections (not requiring intra-venous antibiotic therapy and with no signs of sepsis, i.e. uncomplicated urinary tract infections), Anemia requiring blood transfusions in the absence of shock.
PONV: Postoperative Nausea and Vomiting
delirium and postoperative cognitive dysfunction
mortality
measure: information of hemodynamic and ScvO2 ,types and volumes of all fluids administered
time frame: 24 hours after operation
arm group label: Protocol group 1
arm group type: Other
description: Using standard hemodynamic therapy
arm group label: Protocol group 2
arm group type: Experimental
description: Using goal-directed therapy
intervention type: Procedure
intervention name: Protocol group 2
description: ensure SpO2≥ 92%, MAP 65-100 mmHg, HR <100 bpm, Hb> 8mg/dL and temperature ≥ 36℃, the patients were then administrated a 200 ml colloid as a fluid challenge. The fluid challenge repeat until the SV failed to increase by a factor of 10%. If at this stage the DO2I can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 120 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
arm group label: Protocol group 2
other name: goal-directed therapy
intervention type: Procedure
intervention name: Protocol group 1
description: The goal of this protocol is to ensure MAP> 65 mmHg, CVP 8-12 cmH2O. If meet the above requirements, do nothing, re-evaluate after 5min. If CVP <8 cmH2O, the patient will receive an additional 200ml colloid .If MAP beyond the scope of 65-100 mmHg, vasoactive agents will be administrated until achieve the goal. If 25mL/kg colloid given before goal is achieved, fluid challenges will then be performed with 200mL boluses of Ringer's lactate solution. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
arm group label: Protocol group 1
other name: conventional fluid management
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Xiangcai Ruan, MD, PHD
role: Principal Investigator
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou Medical College
facility: 
country: China
citation: Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PMID: 12357146
citation: Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008 Mar;106(3):867-72, table of contents. doi: 10.1213/ane.0b013e318161964d.
PMID: 18292432
citation: Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
PMID: 21624138
citation: Lees N, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy in high risk surgical patients. Crit Care. 2009;13(5):231. doi: 10.1186/cc8039. Epub 2009 Oct 26.
PMID: 19863764
citation: Moore JM. Continuous spinal anesthesia. Am J Ther. 2009 Jul-Aug;16(4):289-94. doi: 10.1097/MJT.0b013e3181729d2a.
PMID: 19546804
responsible party type: Principal Investigator
investigator affiliation: Guangzhou First People's Hospital
investigator full name: Xiangcai Ruan
investigator title: Professor, Vice Chair
mesh term: Hypoxia
mesh term: Postoperative Complications
mesh term: Hypovolemia