<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/NCT02250131</url>
  </required_header>
  <id_info>
    <org_study_id>GIFT</org_study_id>
    <nct_id>NCT02250131</nct_id>
  </id_info>
  <brief_title>The Goal dIrected perFusion Trial in Cardiac Surgery</brief_title>
  <acronym>GIFT</acronym>
  <official_title>A Multi-center, Randomized Controlled Trial of Goal-directed Perfusion in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide&#xD;
      production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in&#xD;
      cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the&#xD;
      correspondent critical value of DO2/VCO2 ratio is around 5.0.&#xD;
&#xD;
      Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased&#xD;
      incidence of acute kidney injury (AKI) after cardiac operations.&#xD;
&#xD;
      These observations offer an interpretation for the well-known deleterious effects of&#xD;
      excessive hemodilution during CPB, supported by many studies where an association between&#xD;
      nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is&#xD;
      reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the&#xD;
      kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the&#xD;
      oxygen supply.&#xD;
&#xD;
      However, there is no evidence that a strategy directed towards the specific goal of avoiding&#xD;
      critical values of DO2 during CPB may actually decrease the postoperative AKI rate.&#xD;
&#xD;
      The present study is designed to verify the hypothesis that a strategy based on a&#xD;
      goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is&#xD;
      effective in limiting the postoperative AKI rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2. Study design Multicenter, international, prospective, randomized and controlled study.&#xD;
      Patient population&#xD;
&#xD;
        1. Inclusion criteria: Adult (&gt; 18 years) patients undergoing cardiac operations with CPB.&#xD;
&#xD;
           Expected CPB duration &gt; 90 minutes.&#xD;
&#xD;
        2. Exclusion criteria: severe chronic renal failure (dialysis or serum creatinine &gt; 3.0&#xD;
           mg/dL); emergent (must be operated immediately) procedure; moderate-severe anemia&#xD;
           (preoperative HCT &lt; 32%); expected nadir CPB temperature &lt; 32 °C.&#xD;
&#xD;
        3. Withdrawal criteria (after randomization): Need for allogeneic blood transfusions before&#xD;
           CPB. Need for allogeneic blood to prime the CPB circuit. DHCA or other violations of the&#xD;
           entry criteria. CPB duration below 90 minutes will not be withdrawal criterion, but a&#xD;
           subroup analysis is anticipated.&#xD;
&#xD;
      Primary outcomes&#xD;
&#xD;
      Incidence of AKI, defined according to the AKIN criteria (9) as:&#xD;
&#xD;
      AKI stage 1: peak postoperative serum creatinine &gt; 1.5 x baseline or absolute increase 0.3&#xD;
      mg/dL, within the first 48 hours after surgery.&#xD;
&#xD;
      AKI stage 2: peak postoperative serum creatinine &gt; 2.0 x baseline, within the first 48 hours&#xD;
      after surgery (AKI stage 3 will be incorporated in the AKI stage 2 group).&#xD;
&#xD;
      Any AKI: stage 1 or higher Peak serum creatinine: within the first 48 postoperative hours.&#xD;
      Diagnosis of AKI must be reached within the first 48 hours after surgery, but staging may&#xD;
      require a longer time (up to 7 days after surgery).&#xD;
&#xD;
      Secondary outcomes Length of ICU stay (days) Transfusion (red blood cells) rate and amount of&#xD;
      red blood cells units transfused Major morbidity (according to STS): mechanical ventilation &gt;&#xD;
      48 hours, AKI stage 2, surgical revision, mediastinitis, stroke.&#xD;
&#xD;
      Operative (in-hospital) mortality 3. Sample size The power analysis is based on the primary&#xD;
      outcome &quot;any AKI&quot;.&#xD;
&#xD;
      Data from the previous study (1) provide the following figures for the total patient&#xD;
      population:&#xD;
&#xD;
      Any AKI rate: 21.2% AKI stage 1: 8.8% AKI stage 2-3: 12.4% With the following distribution&#xD;
      according to a cut-off value settled at a nadir DO2 of 280 mL/min/m2.&#xD;
&#xD;
      Outcome All cases N=354 DO2 &lt; 280 mL/min/m2 N= 181 DO2 ≥ 280 mL/min/m2 N= 173 P Any AKI 75&#xD;
      (21.2%) 54 (29.8%) 21 (12.1%) 0.001 AKI stage 1 31 (8.8%) 23 (12.7%) 8 (4.6%) 0.007 AKI stage&#xD;
      2-3 44 (12.4%) 31 (17.1%) 13 (7.5%) 0.006&#xD;
&#xD;
      Based on the above table, we know that the Control Group will spontaneously meet the goal in&#xD;
      50% of the cases, and that will have an any AKI rate of 21%.&#xD;
&#xD;
      We hypothesize that the Goal-Directed Perfusion (GDP) group will meet the goal in 95% of the&#xD;
      cases. When the goal is met, the AKIN rate will be 12%; when it is not, it will be 29% This&#xD;
      will lead to an expected AKI rate in GDP group of 12.8%.&#xD;
&#xD;
      Therefore, the effect size will be a 40% reduction in the AKI rate (12.8% in GDP group, 21%&#xD;
      in Control group.&#xD;
&#xD;
      Based on this effect size, an alpha value of 0.05 and a beta value of 0.20, the number of&#xD;
      patients in each group is 350, for a total patient population of 700.&#xD;
&#xD;
      Data analysis will be restricted to patients with a CPB duration &gt; 60 minutes. Same applies&#xD;
      to extremely long CPB duration, based on the percentile distribution of CPB.&#xD;
&#xD;
      Interim analyses planned at 25%, 50%, and 75% of patients enrollment, with stopping rules for&#xD;
      futility, safety, efficacy. Stopping rule for futility: relative risk for the primary outcome&#xD;
      not inclusing the hypothesized value of 0.6 within 99% confidence interval at 50% interim&#xD;
      analysis or 95% at 75% interim analysis. Stopping rule for efficacy in presence of a&#xD;
      difference in favour of the GDP arm at a P value of 0.01 at 25% interim analysis or 0.05 at&#xD;
      the 50% and 75% interim analyses. Stopping rule for safety in presence of a difference in&#xD;
      favor of the control arm at a P value of 0.01 at the 25% interim analysis or 0.05 at the 50%&#xD;
      and 75% interim analyses (Ethics Committe amendment August 2016).&#xD;
&#xD;
      4. Interventions Patients will be randomly allocated to the Control or the GDP group.&#xD;
      Randomization will be performed locally at each participating Institution, using&#xD;
      computer-generated schemes.&#xD;
&#xD;
      The patients in control Group will be treated according to the local standards. The patients&#xD;
      in GDP group will be treated according to the GDP (see table below).&#xD;
&#xD;
      CONTROL (N=350) TREATMENT (N=350) GDP monitor GDP monitor NO Blood prime (withdrawal) NO&#xD;
      Blood prime (withdrawal) Priming volume and nature according to local standards Priming&#xD;
      volume and nature according to local standards Perfusion targeted on body surface area and °C&#xD;
      Perfusion targeted on DO2 ≥ 280 mL/min/m2 Perfusion pressure according to local standards&#xD;
      Perfusion pressure according to local standards Transfusion triggered by HCT according to&#xD;
      local standards Transfusion triggered by venous oxygen saturation &lt; 68% and/or oxygen&#xD;
      extraction rate &gt; 40% Postoperative care according to local standards Postoperative care&#xD;
      according to local standards&#xD;
&#xD;
      Details of the GDP protocol:&#xD;
&#xD;
      The main intervention to achieve the target value of DO2 is increasing the pump flow.&#xD;
      Additional interventions include hemofiltration to increase the HCT.&#xD;
&#xD;
      Transfusion protocol&#xD;
&#xD;
        1. During CPB: Transfusions are mandatory below a HCT of 18%. Transfusions are generally&#xD;
           prohibited for an HCT &gt; 21%. However, based on the individual judgement that the patient&#xD;
           is actually in need for packed red cells, transfusions are allowed between an HCT of 22%&#xD;
           and 24%. In this case, this will be considered as a protocol violation, but the patient&#xD;
           will not be withdrawn.&#xD;
&#xD;
           Transfusions are always prohibited for an HCT &gt; 24%.&#xD;
&#xD;
        2. After CPB: HCT &lt; 18%: packed red cells are mandatory HCT between 19% and 23%: packed red&#xD;
           cells are allowed HCT between 24% and 30%: packed red cells generally prohibited, but&#xD;
           admitted based on physician's judgement. This represents a protocol violation. In this&#xD;
           case, this will be considered as a protocol violation, but the patient will not be&#xD;
           withdrawn.&#xD;
&#xD;
      HCT &gt; 30%: packed red cells are prohibited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of postoperative AKI</measure>
    <time_frame>48 postoperative hours</time_frame>
    <description>Acute kidney injury defined according to the AKIN criteria (stage 1, stage 2, any AKI, serum creatinine increase)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>15 postoperative days</time_frame>
    <description>lenght of postoperative ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion of red blood cells</measure>
    <time_frame>15 postoperative days</time_frame>
    <description>Rate of patients receiving red blood cells; amount of red blood cells used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major morbidity</measure>
    <time_frame>15 postoperative days</time_frame>
    <description>Mechanical ventilation &gt; 48 hours, AKI stage 2, surgical revision, mediastinitis, stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Mortality for any cause within 30 days after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine cardiopulmonary bypass technique. Flow adjusted on BSA and temperature</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Goal Directed Perfusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Perfusion targeted at oxygen delivery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Perfusion targeted at oxygen delivery</intervention_name>
    <description>Flow on cardiopulmonary bypass based on a target oxygen delivery &gt; 280 mL/min/m2</description>
    <arm_group_label>Goal Directed Perfusion</arm_group_label>
    <other_name>Cardiopulmonary bypass machine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cardiac operations with CPB. Expected CPB duration &gt; 90 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria: severe chronic renal failure (dialysis or serum creatinine &gt; 3.0&#xD;
             mg/dL); emergent (must be operated immediately) procedure; moderate-severe anemia&#xD;
             (preoperative HCT &lt; 32%); expected nadir CPB temperature &lt; 32 °C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Ranucci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Policlinico S. Donato</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Ranucci, MD</last_name>
    <phone>+390252774</phone>
    <phone_ext>754</phone_ext>
    <email>cardioanestesia@virgilio.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Valeria Pistuddi</last_name>
    <phone>+390252774</phone>
    <phone_ext>754</phone_ext>
    <email>valeria.pistuddi@virgilio.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese (Milan)</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Ranucci, MD,FESC</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Ranucci M. Perioperative renal failure: hypoperfusion during cardiopulmonary bypass? Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):265-8. doi: 10.1177/1089253207311141.</citation>
    <PMID>18270190</PMID>
  </results_reference>
  <results_reference>
    <citation>Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.</citation>
    <PMID>16731152</PMID>
  </results_reference>
  <results_reference>
    <citation>Ranucci M, Romitti F, Isgro G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. doi: 10.1016/j.athoracsur.2005.05.069.</citation>
    <PMID>16305874</PMID>
  </results_reference>
  <results_reference>
    <citation>de Somer F, Mulholland JW, Bryan MR, Aloisio T, Van Nooten GJ, Ranucci M. O2 delivery and CO2 production during cardiopulmonary bypass as determinants of acute kidney injury: time for a goal-directed perfusion management? Crit Care. 2011 Aug 10;15(4):R192. doi: 10.1186/cc10349.</citation>
    <PMID>21831302</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>February 9, 2017</last_update_submitted>
  <last_update_submitted_qc>February 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Marco Ranucci</investigator_full_name>
    <investigator_title>Director of Cardiothoracic Anesthesia and ICU Dept</investigator_title>
  </responsible_party>
  <keyword>cardiopulmonary bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250131
org study id: GIFT
nct id: NCT02250131
lead sponsor: 
has dmc: No
Previous studies (1-5) have demonstrated that oxygen delivery (DO2) and carbon dioxide
      production (VCO2) during cardiopulmonary bypass (CPB) are associated with renal outcome in
      cardiac surgery. The critical value for DO2 is around 262 - 272 mL/min/m2, and the
      correspondent critical value of DO2/VCO2 ratio is around 5.0.

      Patients with nadir DO2 and DO2/VCO2 ratio below these critical levels have an increased
      incidence of acute kidney injury (AKI) after cardiac operations.

      These observations offer an interpretation for the well-known deleterious effects of
      excessive hemodilution during CPB, supported by many studies where an association between
      nadir hematocrit (HCT) on CPB and bad outcomes (especially renal) was found (6-8). It is
      reasonable to hypothesize that a low oxygen delivery may determine an ischemic damage to the
      kidney, that due to its peculiar circulation is particularly susceptible to a decrease in the
      oxygen supply.

      However, there is no evidence that a strategy directed towards the specific goal of avoiding
      critical values of DO2 during CPB may actually decrease the postoperative AKI rate.

      The present study is designed to verify the hypothesis that a strategy based on a
      goal-directed perfusion, aimed to avoid a nadir DO2 below the critical threshold, is
      effective in limiting the postoperative AKI rate.
2. Study design Multicenter, international, prospective, randomized and controlled study.
      Patient population

        1. Inclusion criteria: Adult (> 18 years) patients undergoing cardiac operations with CPB.

           Expected CPB duration > 90 minutes.

        2. Exclusion criteria: severe chronic renal failure (dialysis or serum creatinine > 3.0
           mg/dL); emergent (must be operated immediately) procedure; moderate-severe anemia
           (preoperative HCT < 32%); expected nadir CPB temperature < 32 °C.

        3. Withdrawal criteria (after randomization): Need for allogeneic blood transfusions before
           CPB. Need for allogeneic blood to prime the CPB circuit. DHCA or other violations of the
           entry criteria. CPB duration below 90 minutes will not be withdrawal criterion, but a
           subroup analysis is anticipated.

      Primary outcomes

      Incidence of AKI, defined according to the AKIN criteria (9) as:

      AKI stage 1: peak postoperative serum creatinine > 1.5 x baseline or absolute increase 0.3
      mg/dL, within the first 48 hours after surgery.

      AKI stage 2: peak postoperative serum creatinine > 2.0 x baseline, within the first 48 hours
      after surgery (AKI stage 3 will be incorporated in the AKI stage 2 group).

      Any AKI: stage 1 or higher Peak serum creatinine: within the first 48 postoperative hours.
      Diagnosis of AKI must be reached within the first 48 hours after surgery, but staging may
      require a longer time (up to 7 days after surgery).

      Secondary outcomes Length of ICU stay (days) Transfusion (red blood cells) rate and amount of
      red blood cells units transfused Major morbidity (according to STS): mechanical ventilation >
      48 hours, AKI stage 2, surgical revision, mediastinitis, stroke.

      Operative (in-hospital) mortality 3. Sample size The power analysis is based on the primary
      outcome "any AKI".

      Data from the previous study (1) provide the following figures for the total patient
      population:

      Any AKI rate: 21.2% AKI stage 1: 8.8% AKI stage 2-3: 12.4% With the following distribution
      according to a cut-off value settled at a nadir DO2 of 280 mL/min/m2.

      Outcome All cases N=354 DO2 < 280 mL/min/m2 N= 181 DO2 ≥ 280 mL/min/m2 N= 173 P Any AKI 75
      (21.2%) 54 (29.8%) 21 (12.1%) 0.001 AKI stage 1 31 (8.8%) 23 (12.7%) 8 (4.6%) 0.007 AKI stage
      2-3 44 (12.4%) 31 (17.1%) 13 (7.5%) 0.006

      Based on the above table, we know that the Control Group will spontaneously meet the goal in
      50% of the cases, and that will have an any AKI rate of 21%.

      We hypothesize that the Goal-Directed Perfusion (GDP) group will meet the goal in 95% of the
      cases. When the goal is met, the AKIN rate will be 12%; when it is not, it will be 29% This
      will lead to an expected AKI rate in GDP group of 12.8%.

      Therefore, the effect size will be a 40% reduction in the AKI rate (12.8% in GDP group, 21%
      in Control group.

      Based on this effect size, an alpha value of 0.05 and a beta value of 0.20, the number of
      patients in each group is 350, for a total patient population of 700.

      Data analysis will be restricted to patients with a CPB duration > 60 minutes. Same applies
      to extremely long CPB duration, based on the percentile distribution of CPB.

      Interim analyses planned at 25%, 50%, and 75% of patients enrollment, with stopping rules for
      futility, safety, efficacy. Stopping rule for futility: relative risk for the primary outcome
      not inclusing the hypothesized value of 0.6 within 99% confidence interval at 50% interim
      analysis or 95% at 75% interim analysis. Stopping rule for efficacy in presence of a
      difference in favour of the GDP arm at a P value of 0.01 at 25% interim analysis or 0.05 at
      the 50% and 75% interim analyses. Stopping rule for safety in presence of a difference in
      favor of the control arm at a P value of 0.01 at the 25% interim analysis or 0.05 at the 50%
      and 75% interim analyses (Ethics Committe amendment August 2016).

      4. Interventions Patients will be randomly allocated to the Control or the GDP group.
      Randomization will be performed locally at each participating Institution, using
      computer-generated schemes.

      The patients in control Group will be treated according to the local standards. The patients
      in GDP group will be treated according to the GDP (see table below).

      CONTROL (N=350) TREATMENT (N=350) GDP monitor GDP monitor NO Blood prime (withdrawal) NO
      Blood prime (withdrawal) Priming volume and nature according to local standards Priming
      volume and nature according to local standards Perfusion targeted on body surface area and °C
      Perfusion targeted on DO2 ≥ 280 mL/min/m2 Perfusion pressure according to local standards
      Perfusion pressure according to local standards Transfusion triggered by HCT according to
      local standards Transfusion triggered by venous oxygen saturation < 68% and/or oxygen
      extraction rate > 40% Postoperative care according to local standards Postoperative care
      according to local standards

      Details of the GDP protocol:

      The main intervention to achieve the target value of DO2 is increasing the pump flow.
      Additional interventions include hemofiltration to increase the HCT.

      Transfusion protocol

        1. During CPB: Transfusions are mandatory below a HCT of 18%. Transfusions are generally
           prohibited for an HCT > 21%. However, based on the individual judgement that the patient
           is actually in need for packed red cells, transfusions are allowed between an HCT of 22%
           and 24%. In this case, this will be considered as a protocol violation, but the patient
           will not be withdrawn.

           Transfusions are always prohibited for an HCT > 24%.

        2. After CPB: HCT < 18%: packed red cells are mandatory HCT between 19% and 23%: packed red
           cells are allowed HCT between 24% and 30%: packed red cells generally prohibited, but
           admitted based on physician's judgement. This represents a protocol violation. In this
           case, this will be considered as a protocol violation, but the patient will not be
           withdrawn.

      HCT > 30%: packed red cells are prohibited.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Incidence of postoperative AKI
time frame: 48 postoperative hours
description: Acute kidney injury defined according to the AKIN criteria (stage 1, stage 2, any AKI, serum creatinine increase)
measure: ICU stay
time frame: 15 postoperative days
description: lenght of postoperative ICU stay
measure: Transfusion of red blood cells
time frame: 15 postoperative days
description: Rate of patients receiving red blood cells; amount of red blood cells used
measure: Major morbidity
time frame: 15 postoperative days
description: Mechanical ventilation > 48 hours, AKI stage 2, surgical revision, mediastinitis, stroke.
measure: Mortality
time frame: 30 days after surgery
description: Mortality for any cause within 30 days after surgery
arm group label: Control
arm group type: No Intervention
description: Routine cardiopulmonary bypass technique. Flow adjusted on BSA and temperature
arm group label: Goal Directed Perfusion
arm group type: Active Comparator
description: Perfusion targeted at oxygen delivery
intervention type: Procedure
intervention name: Perfusion targeted at oxygen delivery
description: Flow on cardiopulmonary bypass based on a target oxygen delivery > 280 mL/min/m2
arm group label: Goal Directed Perfusion
other name: Cardiopulmonary bypass machine
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Ranucci, MD
role: Principal Investigator
affiliation: IRCCS Policlinico S. Donato
last name: Marco Ranucci, MD
phone: +390252774
phone ext: 754
email: cardioanestesia@virgilio.it
last name: Valeria Pistuddi
phone: +390252774
phone ext: 754
email: valeria.pistuddi@virgilio.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Ranucci M. Perioperative renal failure: hypoperfusion during cardiopulmonary bypass? Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):265-8. doi: 10.1177/1089253207311141.
PMID: 18270190
citation: Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.
PMID: 16731152
citation: Ranucci M, Romitti F, Isgro G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. doi: 10.1016/j.athoracsur.2005.05.069.
PMID: 16305874
citation: de Somer F, Mulholland JW, Bryan MR, Aloisio T, Van Nooten GJ, Ranucci M. O2 delivery and CO2 production during cardiopulmonary bypass as determinants of acute kidney injury: time for a goal-directed perfusion management? Crit Care. 2011 Aug 10;15(4):R192. doi: 10.1186/cc10349.
PMID: 21831302
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Marco Ranucci
investigator title: Director of Cardiothoracic Anesthesia and ICU Dept
mesh term: Acute Kidney Injury
sharing ipd: No