<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/NCT02237716</url>
  </required_header>
  <id_info>
    <org_study_id>MN2014</org_study_id>
    <nct_id>NCT02237716</nct_id>
  </id_info>
  <brief_title>Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base&#xD;
      excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid&#xD;
      infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown&#xD;
      in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min&#xD;
      and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two&#xD;
      variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no&#xD;
      significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased&#xD;
      between -20 min and 0 min (P &lt; 0.001) and constantly decreased after 0 min, which remained&#xD;
      below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a&#xD;
      significant persistent increase between -20 min to 0 min (P &lt; 0.001) and between -20 min and&#xD;
      10 min (P &lt; 0.001), respectively. SVV exhibited a dipper-type change shown as a significant&#xD;
      decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P &lt;&#xD;
      0.001), which returned to the baseline after 20 min.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardiac index</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>stroke volume index</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>systolic pressure</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>central venous pressure</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>heart rate</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>peripheral vascular resistance</measure>
    <time_frame>during the procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>base excess</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lactic acid</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DO2I</measure>
    <time_frame>during the procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Craniotomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        scheduled for elective craniotomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria were: being aged between 16 and 70 years;&#xD;
&#xD;
          -  with a body mass index of 18-25 kg/m2;&#xD;
&#xD;
          -  with a physical status classified as ASA class I or II;&#xD;
&#xD;
          -  and scheduled for elective craniotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient would be excluded from this study if the patient had complicating serious&#xD;
             coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia;&#xD;
&#xD;
          -  had a previous history of intra-aortic balloon counterpulsation;&#xD;
&#xD;
          -  exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100&#xD;
             mmHg, or heart rate ≥ 100 bpm on operating room admission;&#xD;
&#xD;
          -  or rejected to participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 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>Xinxin Shao</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <!-- 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/NCT02237716
org study id: MN2014
nct id: NCT02237716
lead sponsor: 
The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base
      excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid
      infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown
      in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min
      and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two
      variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no
      significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased
      between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained
      below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a
      significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and
      10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant
      decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P <
      0.001), which returned to the baseline after 20 min.
observational model: Case-Control
time perspective: Prospective
measure: cardiac index
time frame: during the procedure
measure: stroke volume index
time frame: during the procedure
measure: stroke volume variation
time frame: during the procedure
measure: systolic pressure
time frame: during the procedure
measure: central venous pressure
time frame: during the procedure
measure: heart rate
time frame: during the procedure
measure: peripheral vascular resistance
time frame: during the procedure
measure: base excess
time frame: during the procedure
measure: lactic acid
time frame: during the procedure
measure: DO2I
time frame: during the procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Xinxin Shao
investigator title: Resident