<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/NCT03007537</url>
  </required_header>
  <id_info>
    <org_study_id>CSA-AKI2016</org_study_id>
    <nct_id>NCT03007537</nct_id>
  </id_info>
  <brief_title>The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury</brief_title>
  <official_title>The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney&#xD;
      injury, and trying to provide evidence for protecting the renal function and improving the&#xD;
      prognosis for patients after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients meet the inclusion criteria and agree to sign an informed consent will be randomly&#xD;
      assigned into the control group or erythropoietin group.Interventions will be applied 1&#xD;
      day(24hrs) before the cardiac surgery. Blood and Urine samples will be collected after the&#xD;
      surgery. By using the criterion given by KDIGO2012 and testing the biomarkers for acute&#xD;
      kidney injury, we hope to find out if there is an association between erythropoietin&#xD;
      administration and the occurence of acute kidney injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of funds&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2015</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Acute Kidney Injury</measure>
    <time_frame>7 days</time_frame>
    <description>Occurrence of acute kidney injury according to KDIGO guideline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Renal Replacement Therapy</measure>
    <time_frame>3 months</time_frame>
    <description>suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Cardiac Disease</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erythropoietin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythropoietin</intervention_name>
    <description>10000 IU erythropoietin, subcutaneous injection</description>
    <arm_group_label>Erythropoietin group</arm_group_label>
    <other_name>EPO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% sodium chloride</intervention_name>
    <description>0.9% sodium chloride 1ml, subcutaneous injection</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac surgery</intervention_name>
    <description>included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
    <arm_group_label>Erythropoietin group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>open-heart surgery</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Preoperative hemoglobin&lt;130g/L;&#xD;
&#xD;
          2. Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;&#xD;
&#xD;
          3. Volunteers with informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients combined with infection;&#xD;
&#xD;
          2. Patients with end-stage renal disease and undergoing renal replacement therapy&#xD;
&#xD;
          3. Patients with the history of thromboembolism;&#xD;
&#xD;
          4. Patients with malignant tumor and undergoing chemotherapy;&#xD;
&#xD;
          5. Patients with unmanageable hypertension (systolic pressure&gt;200 mmHg or diastolic&#xD;
             pressure&gt;110mmHg);&#xD;
&#xD;
          6. Patients allergic to erythropoietin;&#xD;
&#xD;
          7. Patients injected erythropoietin within 2 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Chen, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xin Wan, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Changchun Cao, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xin Du, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing First Hospital, Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.</citation>
    <PMID>17804841</PMID>
  </reference>
  <reference>
    <citation>de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.</citation>
    <PMID>23033926</PMID>
  </reference>
  <reference>
    <citation>Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.</citation>
    <PMID>17108342</PMID>
  </reference>
  <reference>
    <citation>Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. N Engl J Med. 1998 Aug 27;339(9):578-83. doi: 10.1056/NEJM199808273390902.</citation>
    <PMID>9718376</PMID>
  </reference>
  <reference>
    <citation>Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081.</citation>
    <PMID>24156702</PMID>
  </reference>
  <reference>
    <citation>Oh SW, Chin HJ, Chae DW, Na KY. Erythropoietin improves long-term outcomes in patients with acute kidney injury after coronary artery bypass grafting. J Korean Med Sci. 2012 May;27(5):506-11. doi: 10.3346/jkms.2012.27.5.506. Epub 2012 Apr 25.</citation>
    <PMID>22563215</PMID>
  </reference>
  <reference>
    <citation>Togel FE, Ahlstrom JD, Yang Y, Hu Z, Zhang P, Westenfelder C. Carbamylated Erythropoietin Outperforms Erythropoietin in the Treatment of AKI-on-CKD and Other AKI Models. J Am Soc Nephrol. 2016 Nov;27(11):3394-3404. doi: 10.1681/ASN.2015091059. Epub 2016 Mar 16.</citation>
    <PMID>26984884</PMID>
  </reference>
  <reference>
    <citation>Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2.</citation>
    <PMID>19494484</PMID>
  </reference>
  <reference>
    <citation>Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.</citation>
    <PMID>23829828</PMID>
  </reference>
  <reference>
    <citation>Tie HT, Luo MZ, Lin D, Zhang M, Wan JY, Wu QC. Erythropoietin administration for prevention of cardiac surgery-associated acute kidney injury: a meta-analysis of randomized controlled trials. Eur J Cardiothorac Surg. 2015 Jul;48(1):32-9. doi: 10.1093/ejcts/ezu378. Epub 2014 Oct 13.</citation>
    <PMID>25312524</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>March 2, 2021</results_first_submitted>
  <results_first_submitted_qc>January 8, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2023</results_first_posted>
  <last_update_submitted>January 8, 2023</last_update_submitted>
  <last_update_submitted_qc>January 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Erythropoietin</keyword>
  <keyword>Cardiac Surgery Associated-acute Kidney Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03007537/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
        <group group_id="P2">
          <title>Erythropoietin Group</title>
          <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
        <group group_id="B2">
          <title>Erythropoietin Group</title>
          <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="46"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="46"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>serum creatinine</title>
          <units>μmo/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="46"/>
                    <count group_id="B2" value="46"/>
                    <count group_id="B3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.5" spread="27.6"/>
                    <measurement group_id="B2" value="76.0" spread="26.2"/>
                    <measurement group_id="B3" value="75.2" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Acute Kidney Injury</title>
        <description>Occurrence of acute kidney injury according to KDIGO guideline</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
          </group>
          <group group_id="O2">
            <title>Erythropoietin Group</title>
            <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Acute Kidney Injury</title>
          <description>Occurrence of acute kidney injury according to KDIGO guideline</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Renal Replacement Therapy</title>
        <description>suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
          </group>
          <group group_id="O2">
            <title>Erythropoietin Group</title>
            <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Renal Replacement Therapy</title>
          <description>suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>pulmonary infection, thrombotic events</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
        <group group_id="E2">
          <title>Erythropoietin Group</title>
          <description>10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery&#xD;
Erythropoietin: 10000 IU erythropoietin, subcutaneous injection&#xD;
cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>pulmonary infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="46"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombotic events</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Xiaobin Ji</name_or_title>
      <organization>Nanjing First Hospital, Nanjing Medical University</organization>
      <phone>13705174622</phone>
      <email>xbji007@126.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03007537
org study id: CSA-AKI2016
nct id: NCT03007537
lead sponsor: 
has dmc: Yes
To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney
      injury, and trying to provide evidence for protecting the renal function and improving the
      prognosis for patients after cardiac surgery.
Patients meet the inclusion criteria and agree to sign an informed consent will be randomly
      assigned into the control group or erythropoietin group.Interventions will be applied 1
      day(24hrs) before the cardiac surgery. Blood and Urine samples will be collected after the
      surgery. By using the criterion given by KDIGO2012 and testing the biomarkers for acute
      kidney injury, we hope to find out if there is an association between erythropoietin
      administration and the occurence of acute kidney injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number of Participants With Acute Kidney Injury
time frame: 7 days
description: Occurrence of acute kidney injury according to KDIGO guideline
measure: Number of Participants With Renal Replacement Therapy
time frame: 3 months
description: suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours.
arm group label: control group
arm group type: Placebo Comparator
description: 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
arm group label: Erythropoietin group
arm group type: Experimental
description: 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
intervention type: Drug
intervention name: Erythropoietin
description: 10000 IU erythropoietin, subcutaneous injection
arm group label: Erythropoietin group
other name: EPO
intervention type: Drug
intervention name: 0.9% sodium chloride
description: 0.9% sodium chloride 1ml, subcutaneous injection
arm group label: control group
other name: saline solution
intervention type: Procedure
intervention name: cardiac surgery
description: included valve, coronary artery bypass graft or surgery for congenital heart diseases
arm group label: Erythropoietin group
arm group label: control group
other name: open-heart surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xin Chen, Doctor
role: Study Chair
affiliation: Nanjing First Hospital, Nanjing Medical University
last name: Xin Wan, Doctor
role: Study Director
affiliation: Nanjing First Hospital, Nanjing Medical University
last name: Changchun Cao, Doctor
role: Study Director
affiliation: Nanjing First Hospital, Nanjing Medical University
last name: Xin Du, Doctor
role: Principal Investigator
affiliation: Nanjing First Hospital, Nanjing Medical University
facility: 
country: China
citation: Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533.
PMID: 17804841
citation: de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.
PMID: 23033926
citation: Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.
PMID: 17108342
citation: Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. N Engl J Med. 1998 Aug 27;339(9):578-83. doi: 10.1056/NEJM199808273390902.
PMID: 9718376
citation: Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081.
PMID: 24156702
citation: Oh SW, Chin HJ, Chae DW, Na KY. Erythropoietin improves long-term outcomes in patients with acute kidney injury after coronary artery bypass grafting. J Korean Med Sci. 2012 May;27(5):506-11. doi: 10.3346/jkms.2012.27.5.506. Epub 2012 Apr 25.
PMID: 22563215
citation: Togel FE, Ahlstrom JD, Yang Y, Hu Z, Zhang P, Westenfelder C. Carbamylated Erythropoietin Outperforms Erythropoietin in the Treatment of AKI-on-CKD and Other AKI Models. J Am Soc Nephrol. 2016 Nov;27(11):3394-3404. doi: 10.1681/ASN.2015091059. Epub 2016 Mar 16.
PMID: 26984884
citation: Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2.
PMID: 19494484
citation: Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.
PMID: 23829828
citation: Tie HT, Luo MZ, Lin D, Zhang M, Wan JY, Wu QC. Erythropoietin administration for prevention of cardiac surgery-associated acute kidney injury: a meta-analysis of randomized controlled trials. Eur J Cardiothorac Surg. 2015 Jul;48(1):32-9. doi: 10.1093/ejcts/ezu378. Epub 2014 Oct 13.
PMID: 25312524
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Heart Diseases
mesh term: Wounds and Injuries
mesh term: Epoetin Alfa
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 