<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/NCT03828565</url>
  </required_header>
  <id_info>
    <org_study_id>2018-37</org_study_id>
    <secondary_id>IDRCB</secondary_id>
    <nct_id>NCT03828565</nct_id>
  </id_info>
  <brief_title>Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow</brief_title>
  <acronym>OCOSO2</acronym>
  <official_title>Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow : Multicentric Randomized Control in Single Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize&#xD;
      vascular filling (VF) because of a failure or an excess of filling is deleterious for the&#xD;
      patient. Several studies have assessed the traditionnal VF based on the clinic and the VF&#xD;
      guided by quantitative critereas. Thus studies have showed a decrease of morbidity and&#xD;
      duration of patients' stay whose the VF was guided even on the long term. So, formal&#xD;
      recommandations of experts (FRE) on the perioperative filling strategy of the SFAR (&#xD;
      Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative&#xD;
      vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The&#xD;
      inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized&#xD;
      its pursuite while the absence of an increase of the ESV after a filling test signifies the&#xD;
      useless and deleterious character of this one. The optimization of perioperative hemodynamics&#xD;
      consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz:&#xD;
      limit of its application to the routine. The central venous oxygen saturation (ScvO2) is&#xD;
      simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The&#xD;
      industry has developed continuous monitoring systems by reflection spectrophotometry using&#xD;
      optical fibers installed in the central venous pathways. In daily practice, the stricto sensu&#xD;
      application of FRE leads to administering an VF up to the limit of the preload dependence&#xD;
      without evaluating the adequacy of the cardiac output, which is not a physiological&#xD;
      situation. This filling is therefore sometimes performed solely on the criteria of preload&#xD;
      dependence while it is potentially deleterious for the patient. No study has compared a&#xD;
      strategy based on the use of ScvO2 and preload dependence with current recommendations based&#xD;
      solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2&#xD;
      in the superior cave territory in intraoperative would allow to detect the patients with an&#xD;
      inadequacy of the cardiac output and thus to select the only ones requiring a vascular&#xD;
      filling. This would reduce postoperative complications related to overfilling, without&#xD;
      exposing the patient to episodes of tissue hypoperfusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.</measure>
    <time_frame>Day 5</time_frame>
    <description>CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Cardiac Flow</condition>
  <arm_group>
    <arm_group_label>ScvO2 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ScvO2 Perioperative continue monitoring</intervention_name>
    <description>ScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective&gt; 8g / dL), SaO2 (objective&gt; 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV&gt; 13%, norepinephrine if PPV&lt;9%, reassess if PPV between 9 and 13%.&#xD;
If VF or norepinephrine does not correct ScvO2 (&gt; 65%), a measurement of arterial lactate is performed. If lactatemia is&gt; 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is &lt;2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary.</description>
    <arm_group_label>ScvO2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;50 years old&#xD;
&#xD;
          -  ASA score ≥ 2&#xD;
&#xD;
          -  requiring a major intra-abdominal scheduled surgery&#xD;
&#xD;
          -  lasting more than 90 min&#xD;
&#xD;
          -  in the visceral surgery, vascular surgery, urological surgery and gynecological&#xD;
             surgery sectors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old&#xD;
&#xD;
          -  Pregnant or brest feeding patients&#xD;
&#xD;
          -  no consentement&#xD;
&#xD;
          -  Unstable acute pathology at the time of surgery (acute heart, respiratory or renal&#xD;
             failure, severe sepsis or septic shock, hemorrhagic shock);&#xD;
&#xD;
          -  rhythm disorders type ACFA early intervention;&#xD;
&#xD;
          -  Palliative surgery, ASA 5;&#xD;
&#xD;
          -  Patient under guardianship or curatorship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Olivier Arnaud</last_name>
    <role>Study Director</role>
    <affiliation>APHM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent ZIELESKIEWICZ, Dr</last_name>
    <phone>+33 491965377</phone>
    <email>laurent.zieleskiewicz@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Laurent Zieleskiewicz</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Laurent Zieleskiewicz, Dr</last_name>
      <phone>+33 491965377</phone>
      <email>laurent.zieleskiewicz@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</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/NCT03828565
org study id: 2018-37
secondary id: IDRCB
nct id: NCT03828565
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize
      vascular filling (VF) because of a failure or an excess of filling is deleterious for the
      patient. Several studies have assessed the traditionnal VF based on the clinic and the VF
      guided by quantitative critereas. Thus studies have showed a decrease of morbidity and
      duration of patients' stay whose the VF was guided even on the long term. So, formal
      recommandations of experts (FRE) on the perioperative filling strategy of the SFAR (
      Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative
      vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The
      inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized
      its pursuite while the absence of an increase of the ESV after a filling test signifies the
      useless and deleterious character of this one. The optimization of perioperative hemodynamics
      consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz:
      limit of its application to the routine. The central venous oxygen saturation (ScvO2) is
      simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The
      industry has developed continuous monitoring systems by reflection spectrophotometry using
      optical fibers installed in the central venous pathways. In daily practice, the stricto sensu
      application of FRE leads to administering an VF up to the limit of the preload dependence
      without evaluating the adequacy of the cardiac output, which is not a physiological
      situation. This filling is therefore sometimes performed solely on the criteria of preload
      dependence while it is potentially deleterious for the patient. No study has compared a
      strategy based on the use of ScvO2 and preload dependence with current recommendations based
      solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2
      in the superior cave territory in intraoperative would allow to detect the patients with an
      inadequacy of the cardiac output and thus to select the only ones requiring a vascular
      filling. This would reduce postoperative complications related to overfilling, without
      exposing the patient to episodes of tissue hypoperfusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Difference of the CCI score at day 5 between patients of ScvO2 group and patient of control group.
time frame: Day 5
description: CCI score : Comprehensive Complication Index. Allow to integrate all the postoperative complications and their respectives severities. From 0 (No complication) to 100 (death of the patient)
arm group label: ScvO2 group
arm group type: Active Comparator
description: ScvO2 and Pulse Pressure Variation (PPV) : every 30 min (%) ScvO2 Evolution in case of corrective maneuver (%) PPV evolution in case of filling test (%)
arm group label: Control group
arm group type: No Intervention
description: End-systolic Volume (ESV) : every 30 min (mL) ESV evolution in case of filling test (%)
intervention type: Procedure
intervention name: ScvO2 Perioperative continue monitoring
description: ScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective> 8g / dL), SaO2 (objective> 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV> 13%, norepinephrine if PPV<9%, reassess if PPV between 9 and 13%.
If VF or norepinephrine does not correct ScvO2 (> 65%), a measurement of arterial lactate is performed. If lactatemia is> 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is <2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary.
arm group label: ScvO2 group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Olivier Arnaud
role: Study Director
affiliation: APHM
last name: Laurent ZIELESKIEWICZ, Dr
phone: +33 491965377
email: laurent.zieleskiewicz@ap-hm.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Postoperative Complications