<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/NCT03807414</url>
  </required_header>
  <id_info>
    <org_study_id>CEAVC14334</org_study_id>
    <nct_id>NCT03807414</nct_id>
  </id_info>
  <brief_title>Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for EBPTs in Critically Ill Patients</brief_title>
  <official_title>Development of a Web-based Multicenter Registry on the Use of oXiris Membrane for Extracorporeal Blood Purification Therapies in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Careggi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Careggi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly&#xD;
      widespread worldwide in everyday clinical practice, particularly in the critical care&#xD;
      setting. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on&#xD;
      patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day-&#xD;
      or hospital- mortality rates. The aim of this observational prospective registry is to&#xD;
      evaluate if there is a cluster of critically ill patients that mostly benefits from&#xD;
      extracorporeal blood purification therapies with oXiris membrane.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly&#xD;
      widespread worldwide in everyday clinical practice, particularly in the critical care&#xD;
      setting. For most of these treatments, the extracorporeal removal of inflammatory mediators&#xD;
      (via enhanced transmembrane clearance and/or selective/un-selective adsorption of bacterial&#xD;
      toxins or inflammatory mediators) is already well established in the literature. Unselective&#xD;
      cytokine removal is the main rationale for the use of EBPT, and it might explain the effect&#xD;
      of these treatments on multiorgan dysfunction in critically ill patients. Indeed, an&#xD;
      increment in hemodynamic stability and an improvement in the multiorgan dysfunction scoring&#xD;
      system of treated patients are consistently observed in most of the studies available in the&#xD;
      literature. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on&#xD;
      patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day-&#xD;
      or hospital- mortality rates.&#xD;
&#xD;
      Interestingly, the post-hoc analysis of large databases suggests that a specific&#xD;
      subpopulation of patients, who are likely to benefit more than others from EBPT, could be&#xD;
      identified in clinical practice. As an example, press releases from the Euphrates trial&#xD;
      suggest that a specific range of baseline endotoxin activity assay might correlate with a&#xD;
      positive long-term outcome in patients treated with Toraymixin cartridges. Nowadays, a&#xD;
      personalized approach to extracorporeal therapy has been advocated as the only strategy&#xD;
      capable of maximizing the clinical effect of EBPT and their impact on patient outcomes (i.e.&#xD;
      precision medicine).&#xD;
&#xD;
      The identification of clinical characteristics correlated with positive outcomes during EBPT&#xD;
      allows the implementation of specifically designed trials, focused on a well-defined cluster&#xD;
      of patients.&#xD;
&#xD;
      The implementation of a large database encompassing the clinical/biochemical characteristics&#xD;
      of patients undergoing EBPT is thus widely hoped for to enable the identification of a&#xD;
      cluster of patients with specific features who most benefit from these treatments.&#xD;
&#xD;
      Although it is well known that only a clinical trial can formally assess the effect of EBPT&#xD;
      on a specific clinical outcome, several drawbacks pose practical limitations to the&#xD;
      implementation of a clinical trial in the critical care setting for this purpose. First, most&#xD;
      European countries (and particularly Italy) do not allow the enrollment and randomization of&#xD;
      non-competent patients (as critically ill patients formally are), due to ethical issues.&#xD;
      Second, clinical trials are associated with very high costs. Third, the quality of results&#xD;
      and conclusions deriving from post-hoc analysis of randomized clinical trials (often&#xD;
      underpowered) may be qualitatively similar to those obtained from a very large database of&#xD;
      patients observed during treatments performed according to the routine clinical practice.&#xD;
&#xD;
      As an example, COMPACT and COMPACT 2 trials, failed to demonstrate a significant effect of&#xD;
      Coupled plasma-filtration adsorption (CPFA) on the outcome of critically ill septic patients,&#xD;
      with the notable exception of specific subpopulations (e.g. those where an adequate volume of&#xD;
      plasma was filtered and adsorbed). This conclusion was obtained through two highly-costly&#xD;
      multicenter randomized clinical trials, prematurely halted due to ethical issues, using&#xD;
      post-hoc analysis of a subgroup of an already limited sample size.&#xD;
&#xD;
      Nowadays, the identification of specific clusters of patients during EBPT is obtained by&#xD;
      means of the implementation of a large web-based registry where a network of researchers can&#xD;
      upload the clinical data of patients undergoing EBPT in line with the routine clinical&#xD;
      practice of each single center. Taking into consideration the feasibility of the research&#xD;
      (i.e. mainly related with the lack of critical ethical issues and the easy-to-use interface&#xD;
      of web-platforms), these observation-based registries are inexpensive and effective tools&#xD;
      able to identify specific clusters of patients within a very large sample size with widely&#xD;
      heterogeneous clinical characteristics.&#xD;
&#xD;
      As an example, a web-based registry has been already implemented to describe the clinical&#xD;
      effects of polymyxin-B based cartridges for endotoxin removal (EUPHAS 2 registry). Another&#xD;
      one has been similarly implemented to describe the clinical effects of un-selective cytokine&#xD;
      adsorption obtained with CytoSorb (CytoSorb registry).&#xD;
&#xD;
      Taking into consideration the fact that data on CPFA already exist and web-based registries&#xD;
      are already available for Toraymixin and for CytoSorb, the aim of this project is to design&#xD;
      and nationally promote a web-based registry specifically designed for oXiris membrane. In&#xD;
      particular, an easy-to-use web-based platform will be made available for all centers that&#xD;
      spontaneously adhere to this project.&#xD;
&#xD;
      Three main characteristics will distinguish this web-based registry of the clinical use of&#xD;
      oXiris membrane when compared with the already available Euphas 2 and CytoSorb registries.&#xD;
      First, it will also be available for smartphone and/or tablet applications; this&#xD;
      characteristic will guarantee easy-to-use access and data uploading and enhanced compliance&#xD;
      from clinical researchers. Second, it will not be confined to a simplistic registration of&#xD;
      patients' data; it will instead also provide the clinician with clinical tools that might be&#xD;
      helpful for patient management (e.g. automatic calculation of clinical scoring systems, ideal&#xD;
      body weight, functions of mechanical ventilation, antibiotic adjustment according to renal&#xD;
      function, etc.). All these tools will provide the clinician with real-time feedback; this&#xD;
      web-based registry will provide a clear example of translational medicine and translational&#xD;
      research, where data from clinical practice will feed a database for clinical research and,&#xD;
      contemporaneously, the research tool will improve clinical practice, providing useful&#xD;
      instruments for routine practice. Finally, this web-based registry will allow every center to&#xD;
      instantaneously evaluate its results, providing a real-time basic statistic for every&#xD;
      recorded variable (e.g. age at enrollment, main comorbidities, baseline serum creatinine,&#xD;
      mortality rate, rate of multidrug resistant bacteria, etc.). This function may allow each&#xD;
      center to continuously monitor outcomes and local practices, and will represent a major&#xD;
      improvement when compared to already existing platforms in Italy, such as the Prosafe.&#xD;
&#xD;
      With this rationale, the research questions are:&#xD;
&#xD;
        -  Is there a cluster of critically ill patients that mostly benefits from extracorporeal&#xD;
           blood purification therapies (EBPT) with oXiris membrane?&#xD;
&#xD;
        -  Might some baseline variables be used to identify this subpopulation of &quot;responsive&quot;&#xD;
           patients? In particular, may these indicators be employed to guide indications for EBPT&#xD;
           with oXiris, in order to personalize treatments and improve patients' long-term outcome?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 28, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Identification of the subpopulation of critically ill patients that most benefits from EBPT with oXiris</measure>
    <time_frame>10 days after EBPT initiation</time_frame>
    <description>This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome. In particular baseline variables statistically associated through multivariable regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Description of the over-time variation of clinical variables during EBPT with oXiris.</measure>
    <time_frame>24 hours after EBPT initiation</time_frame>
    <description>This over-time variation will be expresed, for each variable, as a percentage variation compared with the baseline value (at the EBPT initiation).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Critical Illness</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Sepsis</condition>
  <condition>Systemic Inflammatory Response Syndrome</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>In centres that obtained IRB approval for this prospective study, all critically ill adult patients (&gt;18yrs) undergoing treatment with oXiris will be prospectively observed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>oXiris</intervention_name>
    <description>Every center will prescribe EBPT with oXiris in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All critically ill patients undergoing EBPT with oXiris membrane in the enrolling centers&#xD;
        will be prospectively observed.&#xD;
&#xD;
        Although acute kidney injury will be mostly present among the enrolled population, it will&#xD;
        be not strictly required as an inclusion criterion. Similarly, although sepsis will be&#xD;
        frequently observed, the systemic inflammatory state leading to multiorgan dysfunction and&#xD;
        supported by these extracorporeal treatments might have several different etiologies, such&#xD;
        as ischemia-reperfusion, severe acute pancreatitis, intoxication, etc. (i.e. &quot;sepsis-like&#xD;
        syndromes&quot;).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critically ill patients in the ICU&#xD;
&#xD;
          -  treatment with oXiris&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#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>Gianluca Villa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>U. of Florence- Dept of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Presidio Ospedaliero di Esine</name>
      <address>
        <city>Esine</city>
        <state>Brescia</state>
        <zip>25040</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S. Giuseppe Hospital</name>
      <address>
        <city>Empoli</city>
        <state>Firenze</state>
        <zip>50053</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico S. Donato Milanese</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milano</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sacro Cuore di Gesù-Fatebenefratelli</name>
      <address>
        <city>Benevento</city>
        <zip>82100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. della Campania &quot;L. Vanvitelli&quot;</name>
      <address>
        <city>Napoli</city>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Maria della Misericordia</name>
      <address>
        <city>Perugia</city>
        <zip>06129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Jacopo</name>
      <address>
        <city>Pistoia</city>
        <zip>51100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.Camillo Forlanini Hospital</name>
      <address>
        <city>Roma</city>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cristo Re Hospital</name>
      <address>
        <city>Roma</city>
        <zip>00167</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.</citation>
    <PMID>19531784</PMID>
  </reference>
  <reference>
    <citation>Klein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.</citation>
    <PMID>24916483</PMID>
  </reference>
  <reference>
    <citation>Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.</citation>
    <PMID>24401721</PMID>
  </reference>
  <reference>
    <citation>Cutuli SL, Artigas A, Fumagalli R, Monti G, Ranieri VM, Ronco C, Antonelli M; EUPHAS 2 Collaborative Group. Polymyxin-B hemoperfusion in septic patients: analysis of a multicenter registry. Ann Intensive Care. 2016 Dec;6(1):77. doi: 10.1186/s13613-016-0178-9. Epub 2016 Aug 8.</citation>
    <PMID>27502196</PMID>
  </reference>
  <reference>
    <citation>Friesecke S, Trager K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.</citation>
    <PMID>28871441</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Careggi Hospital</investigator_affiliation>
    <investigator_full_name>Gianluca Villa</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>intensive care unit</keyword>
  <keyword>regisrty</keyword>
  <keyword>endotoxin</keyword>
  <keyword>heparin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Systemic Inflammatory Response Syndrome</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/NCT03807414
org study id: CEAVC14334
nct id: NCT03807414
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly
      widespread worldwide in everyday clinical practice, particularly in the critical care
      setting. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on
      patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day-
      or hospital- mortality rates. The aim of this observational prospective registry is to
      evaluate if there is a cluster of critically ill patients that mostly benefits from
      extracorporeal blood purification therapies with oXiris membrane.
The use of extracorporeal blood purification therapies (EBPT) is becoming increasingly
      widespread worldwide in everyday clinical practice, particularly in the critical care
      setting. For most of these treatments, the extracorporeal removal of inflammatory mediators
      (via enhanced transmembrane clearance and/or selective/un-selective adsorption of bacterial
      toxins or inflammatory mediators) is already well established in the literature. Unselective
      cytokine removal is the main rationale for the use of EBPT, and it might explain the effect
      of these treatments on multiorgan dysfunction in critically ill patients. Indeed, an
      increment in hemodynamic stability and an improvement in the multiorgan dysfunction scoring
      system of treated patients are consistently observed in most of the studies available in the
      literature. Nonetheless, most of the clinical trials aimed at exploring the effect of EBPT on
      patients' long-term outcomes have failed to demonstrate consistent results regarding 28 day-
      or hospital- mortality rates.

      Interestingly, the post-hoc analysis of large databases suggests that a specific
      subpopulation of patients, who are likely to benefit more than others from EBPT, could be
      identified in clinical practice. As an example, press releases from the Euphrates trial
      suggest that a specific range of baseline endotoxin activity assay might correlate with a
      positive long-term outcome in patients treated with Toraymixin cartridges. Nowadays, a
      personalized approach to extracorporeal therapy has been advocated as the only strategy
      capable of maximizing the clinical effect of EBPT and their impact on patient outcomes (i.e.
      precision medicine).

      The identification of clinical characteristics correlated with positive outcomes during EBPT
      allows the implementation of specifically designed trials, focused on a well-defined cluster
      of patients.

      The implementation of a large database encompassing the clinical/biochemical characteristics
      of patients undergoing EBPT is thus widely hoped for to enable the identification of a
      cluster of patients with specific features who most benefit from these treatments.

      Although it is well known that only a clinical trial can formally assess the effect of EBPT
      on a specific clinical outcome, several drawbacks pose practical limitations to the
      implementation of a clinical trial in the critical care setting for this purpose. First, most
      European countries (and particularly Italy) do not allow the enrollment and randomization of
      non-competent patients (as critically ill patients formally are), due to ethical issues.
      Second, clinical trials are associated with very high costs. Third, the quality of results
      and conclusions deriving from post-hoc analysis of randomized clinical trials (often
      underpowered) may be qualitatively similar to those obtained from a very large database of
      patients observed during treatments performed according to the routine clinical practice.

      As an example, COMPACT and COMPACT 2 trials, failed to demonstrate a significant effect of
      Coupled plasma-filtration adsorption (CPFA) on the outcome of critically ill septic patients,
      with the notable exception of specific subpopulations (e.g. those where an adequate volume of
      plasma was filtered and adsorbed). This conclusion was obtained through two highly-costly
      multicenter randomized clinical trials, prematurely halted due to ethical issues, using
      post-hoc analysis of a subgroup of an already limited sample size.

      Nowadays, the identification of specific clusters of patients during EBPT is obtained by
      means of the implementation of a large web-based registry where a network of researchers can
      upload the clinical data of patients undergoing EBPT in line with the routine clinical
      practice of each single center. Taking into consideration the feasibility of the research
      (i.e. mainly related with the lack of critical ethical issues and the easy-to-use interface
      of web-platforms), these observation-based registries are inexpensive and effective tools
      able to identify specific clusters of patients within a very large sample size with widely
      heterogeneous clinical characteristics.

      As an example, a web-based registry has been already implemented to describe the clinical
      effects of polymyxin-B based cartridges for endotoxin removal (EUPHAS 2 registry). Another
      one has been similarly implemented to describe the clinical effects of un-selective cytokine
      adsorption obtained with CytoSorb (CytoSorb registry).

      Taking into consideration the fact that data on CPFA already exist and web-based registries
      are already available for Toraymixin and for CytoSorb, the aim of this project is to design
      and nationally promote a web-based registry specifically designed for oXiris membrane. In
      particular, an easy-to-use web-based platform will be made available for all centers that
      spontaneously adhere to this project.

      Three main characteristics will distinguish this web-based registry of the clinical use of
      oXiris membrane when compared with the already available Euphas 2 and CytoSorb registries.
      First, it will also be available for smartphone and/or tablet applications; this
      characteristic will guarantee easy-to-use access and data uploading and enhanced compliance
      from clinical researchers. Second, it will not be confined to a simplistic registration of
      patients' data; it will instead also provide the clinician with clinical tools that might be
      helpful for patient management (e.g. automatic calculation of clinical scoring systems, ideal
      body weight, functions of mechanical ventilation, antibiotic adjustment according to renal
      function, etc.). All these tools will provide the clinician with real-time feedback; this
      web-based registry will provide a clear example of translational medicine and translational
      research, where data from clinical practice will feed a database for clinical research and,
      contemporaneously, the research tool will improve clinical practice, providing useful
      instruments for routine practice. Finally, this web-based registry will allow every center to
      instantaneously evaluate its results, providing a real-time basic statistic for every
      recorded variable (e.g. age at enrollment, main comorbidities, baseline serum creatinine,
      mortality rate, rate of multidrug resistant bacteria, etc.). This function may allow each
      center to continuously monitor outcomes and local practices, and will represent a major
      improvement when compared to already existing platforms in Italy, such as the Prosafe.

      With this rationale, the research questions are:

        -  Is there a cluster of critically ill patients that mostly benefits from extracorporeal
           blood purification therapies (EBPT) with oXiris membrane?

        -  Might some baseline variables be used to identify this subpopulation of "responsive"
           patients? In particular, may these indicators be employed to guide indications for EBPT
           with oXiris, in order to personalize treatments and improve patients' long-term outcome?
observational model: Cohort
time perspective: Prospective
measure: Identification of the subpopulation of critically ill patients that most benefits from EBPT with oXiris
time frame: 10 days after EBPT initiation
description: This subpopulation will be described using the baseline variables associated with a positive long-term patient's outcome. In particular baseline variables statistically associated through multivariable regression analyses with the patient's survival at hospital discharge will be identified and expressed with their Odds ratios, 95%CI and p-value
measure: Description of the over-time variation of clinical variables during EBPT with oXiris.
time frame: 24 hours after EBPT initiation
description: This over-time variation will be expresed, for each variable, as a percentage variation compared with the baseline value (at the EBPT initiation).
arm group label: Critically ill patients
description: In centres that obtained IRB approval for this prospective study, all critically ill adult patients (>18yrs) undergoing treatment with oXiris will be prospectively observed.
intervention type: Device
intervention name: oXiris
description: Every center will prescribe EBPT with oXiris in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
arm group label: Critically ill patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gianluca Villa, MD
role: Principal Investigator
affiliation: U. of Florence- Dept of Health Sciences
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country: Italy
citation: Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled trial. JAMA. 2009 Jun 17;301(23):2445-52. doi: 10.1001/jama.2009.856.
PMID: 19531784
citation: Klein DJ, Foster D, Schorr CA, Kazempour K, Walker PM, Dellinger RP. The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:218. doi: 10.1186/1745-6215-15-218.
PMID: 24916483
citation: Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.
PMID: 24401721
citation: Cutuli SL, Artigas A, Fumagalli R, Monti G, Ranieri VM, Ronco C, Antonelli M; EUPHAS 2 Collaborative Group. Polymyxin-B hemoperfusion in septic patients: analysis of a multicenter registry. Ann Intensive Care. 2016 Dec;6(1):77. doi: 10.1186/s13613-016-0178-9. Epub 2016 Aug 8.
PMID: 27502196
citation: Friesecke S, Trager K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.
PMID: 28871441
responsible party type: Principal Investigator
investigator affiliation: Careggi Hospital
investigator full name: Gianluca Villa
investigator title: Principal investigator
mesh term: Acute Kidney Injury
mesh term: Critical Illness
mesh term: Systemic Inflammatory Response Syndrome
sharing ipd: No