<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/NCT03753607</url>
  </required_header>
  <id_info>
    <org_study_id>AZ 208/17 and AZ 216/17</org_study_id>
    <nct_id>NCT03753607</nct_id>
  </id_info>
  <brief_title>Predictive Value of Renal Venous Flow Profiles for Acute Kidney Injury After Cardiac Surgery</brief_title>
  <official_title>Predictive Value of Doppler-based Renal Venous Flow Profiles for Risk of Acute Kidney Injury After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The prospective single-center study investigates whether preoperative Doppler-based renal&#xD;
      venous flow profiles predict risk of acute kidney injury after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year, more than three million patients undergo cardiac surgery worldwide. Acute kidney&#xD;
      injury (AKI) complicates as many as 36% of these procedures, doubling total hospital costs.&#xD;
      Even minor changes of serum creatinine in the postoperative period have been associated with&#xD;
      decreased survival. When dialysis is required, short-term mortality may exceed 60%. Moreover,&#xD;
      AKI predicts increased long-term mortality regardless of other risk factors even when kidney&#xD;
      function has recovered. Despite this, clinicians have limited tools to preoperatively&#xD;
      identify patients at risk for AKI. Identification of high-risk patients preoperatively could&#xD;
      impact clinical decision making around surgical technique (e.g. off-pump) and timing of&#xD;
      surgery in addition to perioperative management (hemodynamic monitoring, use of certain&#xD;
      drugs, fluid management etc.).&#xD;
&#xD;
      The prospective single-center study investigates whether abnormal preoperative Doppler-based&#xD;
      renal venous flow profiles as surrogates for right heart failure predict risk of acute kidney&#xD;
      injury after cardiac surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 14, 2022</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>Evaluation of the receiver operating characteristic curve of preoperative renal venous flow profiles to predict AKI after cardiac surgery.</measure>
    <time_frame>preoperative</time_frame>
    <description>Doppler-based renal venous flow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of an AKI risk prediction model based on early postoperative AKI biomarker levels to predict AKI after cardiac surgery.</measure>
    <time_frame>Within 24 hours after surgery</time_frame>
    <description>Assessment of serum proenkephalin a as AKI biomarker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of changes in postoperative renal venous flow profiles with renal recovery after AKI.</measure>
    <time_frame>Measured at Day 1 and Day 7 postoperative</time_frame>
    <description>Doppler-based renal venous flow</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Cardiorenal Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples will be flash-frozen for biomarker analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cardiac surgery (with/without cardiopulmonary bypass) at Department of&#xD;
        Cardiovascular Surgery, University Hospital Giessen and Marburg, Campus Giessen&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing cardiac surgery (with/without cardiopulmonary bypass)&#xD;
&#xD;
          -  Subjects who signed informed consent forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing transcatheter aortic valve implantation or interventional valve&#xD;
             repair&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Pre-diagnosed glomerulonephritis, autosomal dominant polycystic kidney disease or&#xD;
             postrenal obstruction&#xD;
&#xD;
          -  Recipients of solid-organ transplants&#xD;
&#xD;
          -  Chronic kidney disease stage 5 (KDIGO) or need for chronic maintenance renal&#xD;
             replacement therapy&#xD;
&#xD;
          -  Acute kidney injury requiring renal replacement therapy&#xD;
&#xD;
          -  Non-end stage renal disease with extracorporeal or peritoneal ultrafiltration due to&#xD;
             diuretic-resistant fluid overload&#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>Andreas Böning, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Giessen and Marburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Horst-Walter Birk, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital Giessen and Marburg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Giessen and Marburg-Campus Giessen, Department of Cardiovascular Surgery &amp; Department of Nephrology</name>
      <address>
        <city>Giessen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Shimada S, Hirose T, Takahashi C, Sato E, Kinugasa S, Ohsaki Y, Kisu K, Sato H, Ito S, Mori T. Pathophysiological and molecular mechanisms involved in renal congestion in a novel rat model. Sci Rep. 2018 Nov 14;8(1):16808. doi: 10.1038/s41598-018-35162-4.</citation>
    <PMID>30429498</PMID>
  </results_reference>
  <results_reference>
    <citation>Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961.</citation>
    <PMID>30371304</PMID>
  </results_reference>
  <results_reference>
    <citation>Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.</citation>
    <PMID>27179835</PMID>
  </results_reference>
  <results_reference>
    <citation>Nijst P, Martens P, Dupont M, Tang WHW, Mullens W. Intrarenal Flow Alterations During Transition From Euvolemia to Intravascular Volume Expansion in Heart Failure Patients. JACC Heart Fail. 2017 Sep;5(9):672-681. doi: 10.1016/j.jchf.2017.05.006. Epub 2017 Jul 12.</citation>
    <PMID>28711449</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Giessen</investigator_affiliation>
    <investigator_full_name>Faeq Husain-Syed</investigator_full_name>
    <investigator_title>Senior physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Cardio-Renal Syndrome</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03753607
org study id: AZ 208/17 and AZ 216/17
nct id: NCT03753607
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The prospective single-center study investigates whether preoperative Doppler-based renal
      venous flow profiles predict risk of acute kidney injury after cardiac surgery.
Each year, more than three million patients undergo cardiac surgery worldwide. Acute kidney
      injury (AKI) complicates as many as 36% of these procedures, doubling total hospital costs.
      Even minor changes of serum creatinine in the postoperative period have been associated with
      decreased survival. When dialysis is required, short-term mortality may exceed 60%. Moreover,
      AKI predicts increased long-term mortality regardless of other risk factors even when kidney
      function has recovered. Despite this, clinicians have limited tools to preoperatively
      identify patients at risk for AKI. Identification of high-risk patients preoperatively could
      impact clinical decision making around surgical technique (e.g. off-pump) and timing of
      surgery in addition to perioperative management (hemodynamic monitoring, use of certain
      drugs, fluid management etc.).

      The prospective single-center study investigates whether abnormal preoperative Doppler-based
      renal venous flow profiles as surrogates for right heart failure predict risk of acute kidney
      injury after cardiac surgery.
observational model: Case-Control
time perspective: Prospective
measure: Evaluation of the receiver operating characteristic curve of preoperative renal venous flow profiles to predict AKI after cardiac surgery.
time frame: preoperative
description: Doppler-based renal venous flow
measure: Analysis of an AKI risk prediction model based on early postoperative AKI biomarker levels to predict AKI after cardiac surgery.
time frame: Within 24 hours after surgery
description: Assessment of serum proenkephalin a as AKI biomarker
measure: Association of changes in postoperative renal venous flow profiles with renal recovery after AKI.
time frame: Measured at Day 1 and Day 7 postoperative
description: Doppler-based renal venous flow
intervention type: Other
intervention name: No intervention
description: No intervention
Samples will be flash-frozen for biomarker analyses.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Böning, M.D.
role: Study Director
affiliation: University Hospital Giessen and Marburg
last name: Horst-Walter Birk, M.D.
role: Study Director
affiliation: University Hospital Giessen and Marburg
facility: 
country: Germany
citation: Shimada S, Hirose T, Takahashi C, Sato E, Kinugasa S, Ohsaki Y, Kisu K, Sato H, Ito S, Mori T. Pathophysiological and molecular mechanisms involved in renal congestion in a novel rat model. Sci Rep. 2018 Nov 14;8(1):16808. doi: 10.1038/s41598-018-35162-4.
PMID: 30429498
citation: Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961.
PMID: 30371304
citation: Iida N, Seo Y, Sai S, Machino-Ohtsuka T, Yamamoto M, Ishizu T, Kawakami Y, Aonuma K. Clinical Implications of Intrarenal Hemodynamic Evaluation by Doppler Ultrasonography in Heart Failure. JACC Heart Fail. 2016 Aug;4(8):674-82. doi: 10.1016/j.jchf.2016.03.016. Epub 2016 May 11.
PMID: 27179835
citation: Nijst P, Martens P, Dupont M, Tang WHW, Mullens W. Intrarenal Flow Alterations During Transition From Euvolemia to Intravascular Volume Expansion in Heart Failure Patients. JACC Heart Fail. 2017 Sep;5(9):672-681. doi: 10.1016/j.jchf.2017.05.006. Epub 2017 Jul 12.
PMID: 28711449
responsible party type: Principal Investigator
investigator affiliation: University of Giessen
investigator full name: Faeq Husain-Syed
investigator title: Senior physician
mesh term: Acute Kidney Injury
mesh term: Cardio-Renal Syndrome
mesh term: Wounds and Injuries
sharing ipd: Undecided