<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/NCT03756402</url>
  </required_header>
  <id_info>
    <org_study_id>0103/15</org_study_id>
    <nct_id>NCT03756402</nct_id>
  </id_info>
  <brief_title>External Validation of IRRIV Test Relationship With Renal Functional Reserve</brief_title>
  <acronym>IRRIV-RFR</acronym>
  <official_title>The Relationship Between IRRIV and RFR Under Normal Conditions: External Validation</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 investigators&#xD;
      hypothesized that there is a correlation between IRRIV and RFR under normal conditions. For&#xD;
      this purpose, externally validation of IRRIV test is performed in a validation cohort of&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal subjects display a significant capacity to increase in baseline GFR under&#xD;
      physiological needs (e.g. pregnancy) or pathological states (e.g. solitary kidney). This&#xD;
      capacity is known as renal functional reserve (RFR), and it is calculated as the difference&#xD;
      between the measured maximum GFR achieved through a renal stress test and the baseline GFR&#xD;
      measured in rest conditions.In clinical practice, the most common renal stress test is&#xD;
      performed as a standardized protein loading test. In a pilot study, the investigators&#xD;
      demonstrated a significant correlation between RFR and the intra-parenchymal renal resistive&#xD;
      index variation (IRRIV) during an echo renal stress test in a cohort of healthy volunteers.&#xD;
      IRRIV test has proven to be rapid, safe, bedside and easy to perform and it might represent a&#xD;
      preliminary test in screening patients' RFR. For this purpose, externally validation of IRRIV&#xD;
      test is performed in a validation cohort of healthy subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2015</start_date>
  <completion_date type="Actual">January 10, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 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>Externally validate IRRIV test</measure>
    <time_frame>Change from baseline to 60 minutes</time_frame>
    <description>A weight of 10% of the patient's body weight was applied on the abdomen. RRIs were recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached was taken as reference (stress RRI). The IRRIV was defined as the percentage difference between baseline RRI and stress RRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between IRRIV test and RFR</measure>
    <time_frame>Change from baseline to 60 minutes</time_frame>
    <description>Correlation between IRRIV and RFR is tested through a Pearson analysis. 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">47</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <description>All subjects underwent protein loading test and IRRIV test on the same day. The renal resistive index (RRI) measurements were performed by one trained sonographer using a multi-frequency convex probe through a manual RRI calculations. The RRIs were measured on three interlobular arteries (superior, middle and inferior) in each kidney, and expressed as a mean value. RFR was measured using an oral protein loading test and was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Urinary creatinine and sCr were measured by the enzymatic method (IL testTM Instrumentation(R), Laboratory SpA, Milano, Italy) and by ILab650 (Instrumentation Laboratory, Werfen Group, Barcelona, Spain).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects undergoing a protein loading and IRRIV test evaluation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria were:&#xD;
&#xD;
          -  Age more than 18 years old;&#xD;
&#xD;
          -  Baseline estimated GFR, calculated using the chronic kidney disease epidemiology&#xD;
             collaboration (CKD-EPI) equation, greater than or equal to 60 ml/min/1.73 m2.&#xD;
&#xD;
        Exclusion criteria were:&#xD;
&#xD;
          -  Age less than 18 years old;&#xD;
&#xD;
          -  Comorbidities potentially affecting renal function (i.e. arterial hypertension,&#xD;
             diabetes, vasculopathy, etc.;&#xD;
&#xD;
          -  Chronic administration of drugs able to modify renal blood flow and/or GFR&#xD;
             (angiotensin converting enzyme-inhibitors (ACEI), angiotensin receptor blockers (ARB),&#xD;
             calcium channel blockers, loop diuretics etc.);&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Ultrasound evidence of morphological kidney abnormalities and/or renal artery&#xD;
             stenosis;&#xD;
&#xD;
          -  Nonsteroidal anti-inflammatory drugs (NSAIDs) or contrast media in the 2 days before&#xD;
             the tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Ronco, MD</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>PPT SSamomi</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>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>ColorDoppler</keyword>
  <keyword>IRRIV test</keyword>
  <keyword>Renal functional reserve</keyword>
  <keyword>Renal resistive index</keyword>
  <keyword>Ultrasound</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>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/NCT03756402
org study id: 0103/15
nct id: NCT03756402
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 investigators
      hypothesized that there is a correlation between IRRIV and RFR under normal conditions. For
      this purpose, externally validation of IRRIV test is performed in a validation cohort of
      healthy subjects.
Normal subjects display a significant capacity to increase in baseline GFR under
      physiological needs (e.g. pregnancy) or pathological states (e.g. solitary kidney). This
      capacity is known as renal functional reserve (RFR), and it 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. 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. For this purpose, externally validation of IRRIV
      test is performed in a validation cohort of healthy subjects.
observational model: Cohort
time perspective: Prospective
measure: Externally validate IRRIV test
time frame: Change from baseline to 60 minutes
description: A weight of 10% of the patient's body weight was applied on the abdomen. RRIs were recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test. The lowest RRI reached was taken as reference (stress RRI). The IRRIV was defined as the percentage difference between baseline RRI and stress RRI.
measure: Correlation between IRRIV test and RFR
time frame: Change from baseline to 60 minutes
description: Correlation between IRRIV and RFR is tested through a Pearson analysis. Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2) and a positive/uncertain/negative IRRIV is evaluated.
arm group label: Healthy Subjects
description: All subjects underwent protein loading test and IRRIV test on the same day. The renal resistive index (RRI) measurements were performed by one trained sonographer using a multi-frequency convex probe through a manual RRI calculations. The RRIs were measured on three interlobular arteries (superior, middle and inferior) in each kidney, and expressed as a mean value. RFR was measured using an oral protein loading test and was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions. Urinary creatinine and sCr were measured by the enzymatic method (IL testTM Instrumentation(R), Laboratory SpA, Milano, Italy) and by ILab650 (Instrumentation Laboratory, Werfen Group, Barcelona, Spain).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Claudio Ronco, MD
role: Study Director
affiliation: Ospedale San Bortolo di Vicenza
url: https://www.youtube.com/watch?v=9V4RoWvL9cs
description: PPT SSamomi
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
sharing ipd: Undecided