<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/NCT03237351</url>
  </required_header>
  <id_info>
    <org_study_id>2017041102</org_study_id>
    <nct_id>NCT03237351</nct_id>
  </id_info>
  <brief_title>Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection</brief_title>
  <official_title>Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZhiHeng Liu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenzhen Second People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perioperative fluid management is a key component of anesthetic management during thoracic&#xD;
      surgery. On one hand, fluid restriction could compromise perfusion of vital organs and&#xD;
      surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary&#xD;
      complications, notably pulmonary edema, which carries a high mortality rate. Perioperative&#xD;
      fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed.&#xD;
      Therefore, to achieve the balance between preventing fluid overload and optimising organ&#xD;
      perfusion, the practical index to guide fluid management, which can predict whether fluid&#xD;
      loading will improve haemodynamic conditions in an individual patient, would be very valuable&#xD;
      during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of&#xD;
      tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory&#xD;
      variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure&#xD;
      variation] can predict fluid responsiveness in mechanically ventilated patients under various&#xD;
      conditions. Therefore, pressure variations are increasingly being advocated for fluid&#xD;
      management.This study will discuss the effects of pulse pressure variation(PPV) in different&#xD;
      level during anesthesia on patients with oxygenation index and short-term prognosis&#xD;
      undergoing video-assisted thoracoscopic surgery for pneumoresection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Oxygenation Index in 48 hours</measure>
    <time_frame>Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The duration of surgery</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of mechanical ventilation</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crystalloid administered</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colloid administered</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients received vasopressor</measure>
    <time_frame>During surgery period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Before the surgery and 48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukocyte</measure>
    <time_frame>Before the surgery and 48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>Before the surgery and 48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication until hospital discharge</measure>
    <time_frame>1 month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay postoperatively</measure>
    <time_frame>1 month after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Goal-directed Fluid Therapy</condition>
  <arm_group>
    <arm_group_label>Conventional therapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low value of PPV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV &lt; 5%) .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High value of PPV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV &lt; 8%) .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluid therapy</intervention_name>
    <description>Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.</description>
    <arm_group_label>Conventional therapy group</arm_group_label>
    <arm_group_label>High value of PPV group</arm_group_label>
    <arm_group_label>Low value of PPV group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI&#xD;
             18.5 ~ 28 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe&#xD;
             valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte&#xD;
             disturbance before operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shenzhen Second People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.</citation>
    <PMID>19837807</PMID>
  </reference>
  <reference>
    <citation>Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.</citation>
    <PMID>19602972</PMID>
  </reference>
  <reference>
    <citation>Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.</citation>
    <PMID>26440438</PMID>
  </reference>
  <reference>
    <citation>Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.</citation>
    <PMID>23719773</PMID>
  </reference>
  <reference>
    <citation>Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.</citation>
    <PMID>23917675</PMID>
  </reference>
  <reference>
    <citation>Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.</citation>
    <PMID>21088596</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>April 21, 2020</last_update_submitted>
  <last_update_submitted_qc>April 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shenzhen Second People's Hospital</investigator_affiliation>
    <investigator_full_name>ZhiHeng Liu</investigator_full_name>
    <investigator_title>Chair of Department of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>goal-directed fluid therapy</keyword>
  <keyword>thoracic surgery, video-assisted</keyword>
  <keyword>acute lung injury</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03237351
org study id: 2017041102
nct id: NCT03237351
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perioperative fluid management is a key component of anesthetic management during thoracic
      surgery. On one hand, fluid restriction could compromise perfusion of vital organs and
      surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary
      complications, notably pulmonary edema, which carries a high mortality rate. Perioperative
      fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed.
      Therefore, to achieve the balance between preventing fluid overload and optimising organ
      perfusion, the practical index to guide fluid management, which can predict whether fluid
      loading will improve haemodynamic conditions in an individual patient, would be very valuable
      during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of
      tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory
      variations of arterial pressure [i.e. pulse pressure variation (PPV) and systolic pressure
      variation] can predict fluid responsiveness in mechanically ventilated patients under various
      conditions. Therefore, pressure variations are increasingly being advocated for fluid
      management.This study will discuss the effects of pulse pressure variation(PPV) in different
      level during anesthesia on patients with oxygenation index and short-term prognosis
      undergoing video-assisted thoracoscopic surgery for pneumoresection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Baseline Oxygenation Index in 48 hours
time frame: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation
measure: The duration of surgery
time frame: During surgery period
measure: The duration of mechanical ventilation
time frame: During surgery period
measure: Crystalloid administered
time frame: During surgery period
measure: Colloid administered
time frame: During surgery period
measure: Blood loss
time frame: During surgery period
measure: Urine output
time frame: During surgery period
measure: Number of patients received vasopressor
time frame: During surgery period
measure: Blood pressure
time frame: Before the surgery and 48 hours after surgery
measure: Leukocyte
time frame: Before the surgery and 48 hours after surgery
measure: Hematocrit
time frame: Before the surgery and 48 hours after surgery
measure: Complication until hospital discharge
time frame: 1 month after surgery
measure: Hospital stay postoperatively
time frame: 1 month after surgery
arm group label: Conventional therapy group
arm group type: Active Comparator
description: Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.
arm group label: Low value of PPV group
arm group type: Experimental
description: Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV < 5%) .
arm group label: High value of PPV group
arm group type: Experimental
description: Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV < 8%) .
intervention type: Device
intervention name: Fluid therapy
description: Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.
arm group label: Conventional therapy group
arm group label: High value of PPV group
arm group label: Low value of PPV group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
citation: Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PMID: 19837807
citation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
PMID: 19602972
citation: Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.
PMID: 26440438
citation: Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.
PMID: 23719773
citation: Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.
PMID: 23917675
citation: Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.
PMID: 21088596
responsible party type: Sponsor-Investigator
investigator affiliation: Shenzhen Second People's Hospital
investigator full name: ZhiHeng Liu
investigator title: Chair of Department of Anesthesiology
sharing ipd: No