<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/NCT03013621</url>
  </required_header>
  <id_info>
    <org_study_id>6296</org_study_id>
    <nct_id>NCT03013621</nct_id>
  </id_info>
  <brief_title>Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative</brief_title>
  <acronym>COVD</acronym>
  <official_title>Venous Congestion and Acute Renal Failure in Cardiac Surgery Postoperative (COVD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery,&#xD;
      and is a major risk factor for mortality in this context.&#xD;
&#xD;
      The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common&#xD;
      complication, close to 100% if one takes into account the transient dysfunction.&#xD;
&#xD;
      A recent study showed that right ventricular dysfunction and the IRA seemed related, rather&#xD;
      on the slope of venous congestion. We wish to study this phenomenon more specifically in&#xD;
      particular to offer reliable diagnostic markers of venous congestion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quantification of sonographic markers of right ventricular</measure>
    <time_frame>1 hour after cardiac surgery</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Acute Renal Failure (ARF)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consisted of patients in immediate postoperative period of cardiac&#xD;
        surgery, hospitalized in surgical intensive care department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: all major patient&#xD;
&#xD;
          -  Gender: both&#xD;
&#xD;
          -  Subject has signed an informed consent&#xD;
&#xD;
          -  IRA KDIGO stage 1 or urine output &lt;0.5 mL / kg / h for at least 6 hours / elevation&#xD;
             creat&gt; 26.5μmol / L&#xD;
&#xD;
          -  Patient in sinus rhythm at the time of the ultrasound measurements&#xD;
&#xD;
          -  No diuretic since intervention&#xD;
&#xD;
          -  Absence of circulatory failure (low doses of catecholamines tolerated)&#xD;
&#xD;
          -  Extubated: absence of mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic heart failure right&#xD;
&#xD;
          -  Chronic renal failure (GFR &lt;60)&#xD;
&#xD;
          -  Usual treatment with high dose diuretics (furosemide&gt; 40mg / day)&#xD;
&#xD;
          -  Endocarditis&#xD;
&#xD;
          -  Emergency surgery (aortic dissection, emergency bypass surgery) / heart surgery D /&#xD;
             redux&#xD;
&#xD;
          -  Circulatory Support&#xD;
&#xD;
          -  ACFA / electro-paced rhythm&#xD;
&#xD;
          -  Inability to give informed about information (subject in emergencies, understanding of&#xD;
             the subject of difficulty, ...)&#xD;
&#xD;
          -  Topic under judicial protection&#xD;
&#xD;
          -  Topic guardianship or curatorship&#xD;
&#xD;
          -  Pregnancy (women of childbearing age)&#xD;
&#xD;
          -  Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul-Michel MERTES, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Strasbourg, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul-Michel MERTES, MD, PhD</last_name>
    <phone>33 3 69 55 15 78</phone>
    <email>paul-michel.mertes@chru-strasbourg.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mircea CRISTINAR, MD</last_name>
    <phone>33 3 69 55 12 65</phone>
    <email>mircea.cristinar@chru-strasbourg.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service Réanimation chirurgicale cardio-vasculaire - NHC</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Paul-Michel MERTES, MD, PhD</last_name>
      <phone>33 3 69 55 15 78</phone>
      <email>paul-michel.mertes@chru-strasbourg.fr</email>
    </contact>
    <investigator>
      <last_name>Paul-Michel MERTES, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mircea CRISTINAR, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thibaut WIPF, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Failure</keyword>
  <keyword>Renal Insufficiency</keyword>
  <keyword>Acute Renal Failure</keyword>
  <keyword>Acute Renal Injury</keyword>
  <keyword>Kidney Failure</keyword>
  <keyword>Kidney Insufficiency</keyword>
  <keyword>Acute Kidney Failure</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>Ventricular dysfunction</keyword>
  <keyword>Venous congestion</keyword>
  <keyword>Renal function</keyword>
  <keyword>Kidney function</keyword>
  <keyword>Venous heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Hyperemia</mesh_term>
  </condition_browse>
  <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/NCT03013621
org study id: 6296
nct id: NCT03013621
lead sponsor: 
has dmc: No
Acute renal failure (ARF) is a frequent complication in the postoperative cardiac surgery,
      and is a major risk factor for mortality in this context.

      The right ventricular dysfunction post cardiopulmonary bypass (CPB) is also a common
      complication, close to 100% if one takes into account the transient dysfunction.

      A recent study showed that right ventricular dysfunction and the IRA seemed related, rather
      on the slope of venous congestion. We wish to study this phenomenon more specifically in
      particular to offer reliable diagnostic markers of venous congestion.
time perspective: Prospective
measure: Quantification of sonographic markers of right ventricular
time frame: 1 hour after cardiac surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul-Michel MERTES, MD, PhD
role: Study Director
affiliation: University Hospital, Strasbourg, France
last name: Paul-Michel MERTES, MD, PhD
phone: 33 3 69 55 15 78
email: paul-michel.mertes@chru-strasbourg.fr
last name: Mircea CRISTINAR, MD
phone: 33 3 69 55 12 65
email: mircea.cristinar@chru-strasbourg.fr
facility: 
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Acute Kidney Injury
mesh term: Hyperemia
sharing ipd: No