<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/NCT03756376</url>
  </required_header>
  <id_info>
    <org_study_id>35/14</org_study_id>
    <nct_id>NCT03756376</nct_id>
  </id_info>
  <brief_title>The Relationship Between IRRIV and RFR Under Pathologic Conditions</brief_title>
  <acronym>IRRIV-RFR</acronym>
  <official_title>The Relationship Between IRRIV and RFR Under Pathologic Conditions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Bortolo di Vicenza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale San Bortolo di Vicenza</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>
      The assessment of renal functional reserve (RFR) has been proposed for the risk&#xD;
      stratification of patients undergoing potentially nephrotoxic procedures. The present pilot&#xD;
      study is designed to explore the correlation between IRRIV and RFR under pathologic&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Renal functional reserve (RFR) represents the capacity of the kidney to increase glomerular&#xD;
      filtration rate (GFR) in response to certain physiological or pathological stimuli or&#xD;
      conditions.&#xD;
&#xD;
      RFR is calculated as the difference between the measured maximum GFR achieved through a renal&#xD;
      stress test and the baseline GFR measured in rest conditions. In clinical practice, the most&#xD;
      common renal stress test is performed as a standardized protein loading test. Recently, in a&#xD;
      pilot study, the investigators demonstrated a significant correlation between RFR and the&#xD;
      intra-parenchymal renal resistive index variation (IRRIV) during an echo renal stress test in&#xD;
      a cohort of healthy volunteers. IRRIV test has proven to be rapid, safe, bedside and easy to&#xD;
      perform and it might represent a preliminary test in screening patients' RFR.The present&#xD;
      pilot study is designed to explore the correlation between IRRIV and RFR under pathologic&#xD;
      conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2015</start_date>
  <completion_date type="Actual">January 13, 2016</completion_date>
  <primary_completion_date type="Actual">November 10, 2015</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>Correlation between IRRIV test and RFR in cardiac surgery patients</measure>
    <time_frame>Change from baseline to 60 minutes</time_frame>
    <description>IRRIV test and RFR will be determined and a relationship will be assessed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance between IRRIV test and RFR in cardiac surgery patients</measure>
    <time_frame>Change from baseline to 60 minutes</time_frame>
    <description>Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2) and a positive/uncertain/negative IRRIV is evaluated.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>IRRIV and RFR</arm_group_label>
    <description>Enrolled patients will receive IRRIV test and RFR assessment. RFR will be evaluated through a protein loading test. (1.2 g of protein/Kg of body weight) performed with cooked beef. The RFR was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Concerning the IRRIV test, a weight of 10% of the patient's body weight is applied on the abdominal wall. RRIs is recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached is taken as reference (stress RRI). The IRRIV is defined as the percentage difference between baseline RRI and stress RRI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for cardiac surgery with cardiopulmonary bypass (coronary artery bypass,&#xD;
        valve replacements, combined or other operations)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated GFR (CKD-EPI) greater than or equal to 60 mL/min/1.73 m2&#xD;
&#xD;
          -  Scheduled cardiac surgery with cardiopulmonary bypass (coronary artery bypass, valve&#xD;
             replacements, combined or other operations).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years old&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis&#xD;
&#xD;
          -  Nonsteroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  Contrast media in the 2 days before the tests.&#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>Claudio Ronco</last_name>
    <role>Study Director</role>
    <affiliation>Ospedale San Bortolo di Vicenza</affiliation>
  </overall_official>
  <link>
    <url>https://www.youtube.com/watch?v=9V4RoWvL9cs</url>
    <description>SSamoni ppt</description>
  </link>
  <results_reference>
    <citation>Samoni S, Nalesso F, Meola M, Villa G, De Cal M, De Rosa S, Petrucci I, Brendolan A, Rosner MH, Ronco C. Intra-Parenchymal Renal Resistive Index Variation (IRRIV) Describes Renal Functional Reserve (RFR): Pilot Study in Healthy Volunteers. Front Physiol. 2016 Jul 6;7:286. doi: 10.3389/fphys.2016.00286. eCollection 2016.</citation>
    <PMID>27458386</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale San Bortolo di Vicenza</investigator_affiliation>
    <investigator_full_name>Sara Samoni</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <!-- 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/NCT03756376
org study id: 35/14
nct id: NCT03756376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The assessment of renal functional reserve (RFR) has been proposed for the risk
      stratification of patients undergoing potentially nephrotoxic procedures. The present pilot
      study is designed to explore the correlation between IRRIV and RFR under pathologic
      conditions.
Renal functional reserve (RFR) represents the capacity of the kidney to increase glomerular
      filtration rate (GFR) in response to certain physiological or pathological stimuli or
      conditions.

      RFR is calculated as the difference between the measured maximum GFR achieved through a renal
      stress test and the baseline GFR measured in rest conditions. In clinical practice, the most
      common renal stress test is performed as a standardized protein loading test. Recently, in a
      pilot study, the investigators demonstrated a significant correlation between RFR and the
      intra-parenchymal renal resistive index variation (IRRIV) during an echo renal stress test in
      a cohort of healthy volunteers. IRRIV test has proven to be rapid, safe, bedside and easy to
      perform and it might represent a preliminary test in screening patients' RFR.The present
      pilot study is designed to explore the correlation between IRRIV and RFR under pathologic
      conditions.
observational model: Cohort
time perspective: Prospective
measure: Correlation between IRRIV test and RFR in cardiac surgery patients
time frame: Change from baseline to 60 minutes
description: IRRIV test and RFR will be determined and a relationship will be assessed
measure: Concordance between IRRIV test and RFR in cardiac surgery patients
time frame: Change from baseline to 60 minutes
description: Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2) and a positive/uncertain/negative IRRIV is evaluated.
arm group label: IRRIV and RFR
description: Enrolled patients will receive IRRIV test and RFR assessment. RFR will be evaluated through a protein loading test. (1.2 g of protein/Kg of body weight) performed with cooked beef. The RFR was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Concerning the IRRIV test, a weight of 10% of the patient's body weight is applied on the abdominal wall. RRIs is recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached is taken as reference (stress RRI). The IRRIV is defined as the percentage difference between baseline RRI and stress RRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudio Ronco
role: Study Director
affiliation: Ospedale San Bortolo di Vicenza
url: https://www.youtube.com/watch?v=9V4RoWvL9cs
description: SSamoni ppt
citation: Samoni S, Nalesso F, Meola M, Villa G, De Cal M, De Rosa S, Petrucci I, Brendolan A, Rosner MH, Ronco C. Intra-Parenchymal Renal Resistive Index Variation (IRRIV) Describes Renal Functional Reserve (RFR): Pilot Study in Healthy Volunteers. Front Physiol. 2016 Jul 6;7:286. doi: 10.3389/fphys.2016.00286. eCollection 2016.
PMID: 27458386
responsible party type: Principal Investigator
investigator affiliation: Ospedale San Bortolo di Vicenza
investigator full name: Sara Samoni
investigator title: Medical Doctor
mesh term: Acute Kidney Injury