<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/NCT03281707</url>
  </required_header>
  <id_info>
    <org_study_id>R627/17-CCM 662</org_study_id>
    <nct_id>NCT03281707</nct_id>
  </id_info>
  <brief_title>NIRS and DO2i Correlation</brief_title>
  <official_title>Evaluation of NIRS and DO2i Correlation and Their Relationship With Organ Failure During Cardiac Surgery: a Prospective Monocentric Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Cardiologico Monzino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Cardiologico Monzino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the association between near infrared spectroscopy (NIRS) and indexed&#xD;
      oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Literature evidences show that levels of DO2i under 262-272 mL/min/m2 during cardiopulmonary&#xD;
      by-pass (CPB) are associated with an increased incidence of acute kidney injury (AKI).&#xD;
&#xD;
      Furthermore, it has been demonstrated that keeping a NIRS of 75-80% compared to the basal&#xD;
      value reduces the risk of perioperative morbidity. On the other hand, a NIRS &lt; 50% of basal&#xD;
      value seems to be predictive of an increase in morbidity.&#xD;
&#xD;
      All of those studies had been performed during CPB and knowledge lacks in management of DO2i&#xD;
      and NIRS before and after CPB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 30, 2017</start_date>
  <completion_date type="Anticipated">October 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>7 Days</target_duration>
  <primary_outcome>
    <measure>Evaluate the correlation between NIRS and DO2i during cardiac surgery</measure>
    <time_frame>Intraoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the correlation between NIRS, DO2i and SOFA score</measure>
    <time_frame>7 days postoperative</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Multiorgan Failure</condition>
  <condition>Perfusion; Complications</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>NIRS</intervention_name>
    <description>NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DO2i</intervention_name>
    <description>Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing cardiac surgery with cardiopulmonary by-pass whose have been&#xD;
             signed the consent informed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibilty to collect a correct continuous cardiac output measure with PiCCO&#xD;
             (chronic atrial fibrillation or severe peripheral vasculopaty)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luca Salvi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Cardiologico Monzino</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luca Salvi, MD</last_name>
    <phone>+390258002541</phone>
    <email>luca.salvi@ccfm.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matteo Nafi, MD</last_name>
    <phone>+390258002879</phone>
    <email>matteo.nafi@ccfm.it</email>
  </overall_contact_backup>
  <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>
  <results_reference>
    <citation>Nielsen HB, Borglum J. Cerebral oxygenation in heart surgery. Anesth Analg. 2007 Aug;105(2):537; author reply 538-9. doi: 10.1213/01.ane.0000265698.02800.d4. No abstract available.</citation>
    <PMID>17646526</PMID>
  </results_reference>
  <results_reference>
    <citation>Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.</citation>
    <PMID>8844239</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Cardiologico Monzino</investigator_affiliation>
    <investigator_full_name>luca salvi</investigator_full_name>
    <investigator_title>Anesthesia and ICU director</investigator_title>
  </responsible_party>
  <keyword>NIRS</keyword>
  <keyword>DO2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Organ Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03281707
org study id: R627/17-CCM 662
nct id: NCT03281707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the association between near infrared spectroscopy (NIRS) and indexed
      oxygen delivery (DO2i) and their possible correlation with postoperative organ failure.
Literature evidences show that levels of DO2i under 262-272 mL/min/m2 during cardiopulmonary
      by-pass (CPB) are associated with an increased incidence of acute kidney injury (AKI).

      Furthermore, it has been demonstrated that keeping a NIRS of 75-80% compared to the basal
      value reduces the risk of perioperative morbidity. On the other hand, a NIRS < 50% of basal
      value seems to be predictive of an increase in morbidity.

      All of those studies had been performed during CPB and knowledge lacks in management of DO2i
      and NIRS before and after CPB.
observational model: Cohort
time perspective: Prospective
measure: Evaluate the correlation between NIRS and DO2i during cardiac surgery
time frame: Intraoperative
measure: Evaluate the correlation between NIRS, DO2i and SOFA score
time frame: 7 days postoperative
intervention type: Procedure
intervention name: NIRS
description: NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere
intervention type: Other
intervention name: DO2i
description: Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luca Salvi, MD
role: Principal Investigator
affiliation: Centro Cardiologico Monzino
last name: Luca Salvi, MD
phone: +390258002541
email: luca.salvi@ccfm.it
last name: Matteo Nafi, MD
phone: +390258002879
email: matteo.nafi@ccfm.it
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
citation: Nielsen HB, Borglum J. Cerebral oxygenation in heart surgery. Anesth Analg. 2007 Aug;105(2):537; author reply 538-9. doi: 10.1213/01.ane.0000265698.02800.d4. No abstract available.
PMID: 17646526
citation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PMID: 8844239
responsible party type: Principal Investigator
investigator affiliation: Centro Cardiologico Monzino
investigator full name: luca salvi
investigator title: Anesthesia and ICU director
mesh term: Multiple Organ Failure
sharing ipd: Undecided