<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/NCT02192502</url>
  </required_header>
  <id_info>
    <org_study_id>012-973</org_study_id>
    <nct_id>NCT02192502</nct_id>
  </id_info>
  <brief_title>Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients</brief_title>
  <acronym>SHARP</acronym>
  <official_title>A Randomized Controlled Investigation of the Effects of 6% Hydroxyethylstarch 130/0.4 (Voluven) on Renal Function in Patients Having Aortic Valve Replacement With or Without Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of a standard volume replacement called&#xD;
      HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an&#xD;
      alternative to pure fluid replacement solutions that are associated with problems after&#xD;
      surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4&#xD;
      (Voluven) will be evaluated by examining its effects on kidney function, and coagulation&#xD;
      parameters and platelet (part of the blood that help it clot) function.&#xD;
&#xD;
      Participants will be randomized (like flipping a coin) to receive one of two possible volume&#xD;
      replacements during surgery, if fluid volume decreases enough to need replacement with one of&#xD;
      the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or&#xD;
      human albumin 5% (a protein-containing solution).&#xD;
&#xD;
      To examine kidney function, urine will be-sampled when the participant is put under general&#xD;
      anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours&#xD;
      after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established&#xD;
      line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24&#xD;
      hours after surgery and every morning during the participants postoperative ICU stay.&#xD;
&#xD;
      Additionally, health and recovery information will be recorded from the participant's medical&#xD;
      record. We will phone participants around 90 days and one year after surgery to ask a few&#xD;
      questions about one's health and recovery. We will also record blood sample analysis results&#xD;
      from follow up appointments within the first year after surgery. If this analysis is not&#xD;
      conducted at the Cleveland Clinic, with permission, we will obtain the results from a&#xD;
      treating physician.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]</measure>
    <time_frame>3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery</time_frame>
    <description>To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kidney Function</measure>
    <time_frame>within first 7 postoperative days</time_frame>
    <description>Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.&#xD;
RIFLE classification criteria is listed below:&#xD;
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function &gt; 4 weeks End stage (RIFLE-E) End-stage kidney failure &gt; 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postop Urine IL-18</measure>
    <time_frame>postoperative 1 hour</time_frame>
    <description>Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postop Urine IL-18</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Postoperative Kidney Injury</condition>
  <arm_group>
    <arm_group_label>HES 130/0.4 (Voluven)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6% HES 130/0.4 during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>human albumin 5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>human albumin 5% during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>human albumin 5%</intervention_name>
    <arm_group_label>human albumin 5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HES 130/0.4 (Voluven)</intervention_name>
    <arm_group_label>HES 130/0.4 (Voluven)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50 - 85 years old&#xD;
&#xD;
          -  Scheduled for elective aortic valve replacement with or without coronary artery bypass&#xD;
             grafting with or without additional minor surgical procedure.&#xD;
&#xD;
          -  Written, informed consent for participation in this investigation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with renal failure with oliguria or anuria not related to hypovolemia.&#xD;
&#xD;
          -  Patients receiving dialysis.&#xD;
&#xD;
          -  Patients with preoperative renal insufficiency (Creatinine &gt; 1.6 mg/dL)&#xD;
&#xD;
          -  Anticipated deep hypothermic circulatory arrest&#xD;
&#xD;
          -  Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of&#xD;
             hydroxyethyl starch&#xD;
&#xD;
          -  Clinical conditions with volume overload (e.g., patients in pulmonary edema or&#xD;
             congestive heart failure)&#xD;
&#xD;
          -  Patients with severe hypernatremia or severe hyperchloremia&#xD;
&#xD;
          -  Patients with intracranial bleeding&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Critically ill adult patients, including patients with sepsis, due to increased risk&#xD;
             of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the&#xD;
             intensive care unit prior to surgery)&#xD;
&#xD;
          -  Severe liver disease&#xD;
&#xD;
          -  Pre-existing coagulation or bleeding disorders&#xD;
&#xD;
          -  Any contraindications to proposed interventions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andra Duncan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>September 21, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2023</results_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>June 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT02192502/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>9 more patients were recruited due to withdrawal (patients did not receive any treatment).</recruitment_details>
      <pre_assignment_details>9 more patients were recruited to ensure enough power after excluding patients who were randomized but they withdrew from the study and did not receive any treatment (see periods section for details).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>HES 130/0.4 (Voluven)</title>
          <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
        </group>
        <group group_id="P2">
          <title>Human Albumin 5%</title>
          <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not receive intervention due to euvolemia</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not receive intervention due to circulatory arrest</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>did not receive intervention due to logistic reasons</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HES 130/0.4 (Voluven)</title>
          <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
        </group>
        <group group_id="B2">
          <title>Human Albumin 5%</title>
          <description>human albumin 5% during surgery&#xD;
human albumin 5%</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="69"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="141"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" spread="10"/>
                    <measurement group_id="B2" value="69" spread="9"/>
                    <measurement group_id="B3" value="70" spread="9"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Myocardial infarction</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgery type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Aortic valve only</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Aortic valve + CABG</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Aortic valve + other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Aortic valve + CABG + other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of aortic cross-clamp</title>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65" lower_limit="48" upper_limit="91"/>
                    <measurement group_id="B2" value="60" lower_limit="45" upper_limit="89"/>
                    <measurement group_id="B3" value="62" lower_limit="46" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total fluid</title>
          <description>total fluid is the amount of colloids and crystalloids during surgery</description>
          <units>L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.8" lower_limit="2.3" upper_limit="3.2"/>
                    <measurement group_id="B2" value="2.8" lower_limit="2.1" upper_limit="3.7"/>
                    <measurement group_id="B3" value="2.8" lower_limit="2.1" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Transfusion</title>
          <description>&quot;Transfusion&quot; Row is reporting the total number of participants who had at least one transfusion</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Red blood cell</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fresh frozen plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cryoprecipitate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transfusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Volume of study solution</title>
          <units>ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="500" lower_limit="400" upper_limit="750"/>
                    <measurement group_id="B2" value="750" lower_limit="500" upper_limit="1000"/>
                    <measurement group_id="B3" value="620" lower_limit="460" upper_limit="800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous cardiac surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of antifibrinolytic drug</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]</title>
        <description>To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.</description>
        <time_frame>3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HES 130/0.4 (Voluven)</title>
            <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
          </group>
          <group group_id="O2">
            <title>Human Albumin 5%</title>
            <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
          </group>
        </group_list>
        <measure>
          <title>Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]</title>
          <description>To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.</description>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="1.8" upper_limit="5.4"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.2" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 1 hour after surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="1.4" upper_limit="68"/>
                    <measurement group_id="O2" value="4.7" lower_limit="1.6" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>at 24 hours after surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="6.8" upper_limit="23"/>
                    <measurement group_id="O2" value="15" lower_limit="7.1" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority delta of a ratio of geometric means is 1.15.</non_inferiority_desc>
            <p_value>0.15</p_value>
            <method>generalized linear model</method>
            <method_desc>This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.</method_desc>
            <param_type>Geometric mean ratio</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kidney Function</title>
        <description>Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.&#xD;
RIFLE classification criteria is listed below:&#xD;
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function &gt; 4 weeks End stage (RIFLE-E) End-stage kidney failure &gt; 3 months</description>
        <time_frame>within first 7 postoperative days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HES 130/0.4 (Voluven)</title>
            <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
          </group>
          <group group_id="O2">
            <title>Human Albumin 5%</title>
            <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
          </group>
        </group_list>
        <measure>
          <title>Kidney Function</title>
          <description>Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.&#xD;
RIFLE classification criteria is listed below:&#xD;
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function &gt; 4 weeks End stage (RIFLE-E) End-stage kidney failure &gt; 3 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>the delta for non-inferiority is 1.15</non_inferiority_desc>
            <p_value>0.92</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>2.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>12.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postop Urine IL-18</title>
        <description>Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU</description>
        <time_frame>postoperative 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HES 130/0.4 (Voluven)</title>
            <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
          </group>
          <group group_id="O2">
            <title>Human Albumin 5%</title>
            <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
          </group>
        </group_list>
        <measure>
          <title>Postop Urine IL-18</title>
          <description>Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU</description>
          <units>pg/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="3" upper_limit="33"/>
                    <measurement group_id="O2" value="16" lower_limit="5" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>the non-inferiority delta was 1.15</non_inferiority_desc>
            <p_value>0.002</p_value>
            <method>Regression, Linear</method>
            <method_desc>IL-18 was log-transformed</method_desc>
            <param_type>geometric mean ratio</param_type>
            <param_value>0.45</param_value>
            <ci_percent>5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postop Urine IL-18</title>
        <description>Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HES 130/0.4 (Voluven)</title>
            <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
          </group>
          <group group_id="O2">
            <title>Human Albumin 5%</title>
            <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
          </group>
        </group_list>
        <measure>
          <title>Postop Urine IL-18</title>
          <description>Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery</description>
          <units>pg/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="37" upper_limit="91"/>
                    <measurement group_id="O2" value="53" lower_limit="29" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>the delta for non-inferiority is 1.15</non_inferiority_desc>
            <p_value>0.31</p_value>
            <method>Regression, Linear</method>
            <method_desc>IL-18 was log-transformed</method_desc>
            <param_type>geometric mean ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>2.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Kidney Function</title>
        <description>kidney injury using RIFLE criteria based on both peak creatinine levels and urine output, as recommended by Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group&#xD;
RIFLE classification criteria is listed below:&#xD;
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline urine output &lt; 0.5 mL/kg/hr for more than 6 hrs Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline urine output &lt; 0.5 mL/kg/hr for more than 12 hrs Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline urine output &lt; 0.3 mL/kg/hr for 24 hrs or anuria for 12 hrs Loss (RIFLE-L) Complete loss of kidney function &gt; 4 weeks End stage (RIFLE-E) End-stage kidney failure &gt; 3 months</description>
        <time_frame>within the first seven postoperative days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HES 130/0.4 (Voluven)</title>
            <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
          </group>
          <group group_id="O2">
            <title>Human Albumin 5%</title>
            <description>human albumin 5% during surgery&#xD;
human albumin 5%</description>
          </group>
        </group_list>
        <measure>
          <title>Kidney Function</title>
          <description>kidney injury using RIFLE criteria based on both peak creatinine levels and urine output, as recommended by Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group&#xD;
RIFLE classification criteria is listed below:&#xD;
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline urine output &lt; 0.5 mL/kg/hr for more than 6 hrs Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline urine output &lt; 0.5 mL/kg/hr for more than 12 hrs Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline urine output &lt; 0.3 mL/kg/hr for 24 hrs or anuria for 12 hrs Loss (RIFLE-L) Complete loss of kidney function &gt; 4 weeks End stage (RIFLE-E) End-stage kidney failure &gt; 3 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Risk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injury</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority delta was 1.15</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HES 130/0.4 (Voluven)</title>
          <description>6% HES 130/0.4 during surgery&#xD;
HES 130/0.4 (Voluven)</description>
        </group>
        <group group_id="E2">
          <title>Human Albumin 5%</title>
          <description>human albumin 5% during surgery&#xD;
human albumin 5%</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="69"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="69"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>cardiac-related</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="69"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>respiratory related event</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="69"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="69"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Andra Duncan</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-538-6944</phone>
      <email>duncana@ccf.org</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/NCT02192502
org study id: 012-973
nct id: NCT02192502
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety of a standard volume replacement called
      HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an
      alternative to pure fluid replacement solutions that are associated with problems after
      surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4
      (Voluven) will be evaluated by examining its effects on kidney function, and coagulation
      parameters and platelet (part of the blood that help it clot) function.

      Participants will be randomized (like flipping a coin) to receive one of two possible volume
      replacements during surgery, if fluid volume decreases enough to need replacement with one of
      the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or
      human albumin 5% (a protein-containing solution).

      To examine kidney function, urine will be-sampled when the participant is put under general
      anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours
      after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established
      line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24
      hours after surgery and every morning during the participants postoperative ICU stay.

      Additionally, health and recovery information will be recorded from the participant's medical
      record. We will phone participants around 90 days and one year after surgery to ask a few
      questions about one's health and recovery. We will also record blood sample analysis results
      from follow up appointments within the first year after surgery. If this analysis is not
      conducted at the Cleveland Clinic, with permission, we will obtain the results from a
      treating physician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes]
time frame: 3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery
description: To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery.
measure: Kidney Function
time frame: within first 7 postoperative days
description: Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis.
RIFLE classification criteria is listed below:
Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function > 4 weeks End stage (RIFLE-E) End-stage kidney failure > 3 months
measure: Postop Urine IL-18
time frame: postoperative 1 hour
description: Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU
measure: Postop Urine IL-18
time frame: 24 hours after surgery
description: Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery
arm group label: HES 130/0.4 (Voluven)
arm group type: Experimental
description: 6% HES 130/0.4 during surgery
arm group label: human albumin 5%
arm group type: Active Comparator
description: human albumin 5% during surgery
intervention type: Drug
intervention name: human albumin 5%
arm group label: human albumin 5%
intervention type: Drug
intervention name: HES 130/0.4 (Voluven)
arm group label: HES 130/0.4 (Voluven)
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andra Duncan, M.D.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 