<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/NCT02225431</url>
  </required_header>
  <id_info>
    <org_study_id>Prato0706</org_study_id>
    <secondary_id>2013/1</secondary_id>
    <nct_id>NCT02225431</nct_id>
  </id_info>
  <brief_title>Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis</brief_title>
  <official_title>Personalized Versus Standard Hydration for Prevention of Contrast Induced Acute Kidney Injury. A Randomized Trial With Bioimpedance Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale Misericordia e Dolce</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ospedale Misericordia e Dolce</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate, in patients with &quot;lower fluid status&quot; defined by&#xD;
      bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are&#xD;
      associated with different volume expansion and differing risks for CI-AKI in patients&#xD;
      undergoing coronary angiographic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in&#xD;
      patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute&#xD;
      kidney injury, CI-AKI).&#xD;
&#xD;
      Several protocols have been tested for the prevention of CI-AKI, including periprocedural&#xD;
      hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or&#xD;
      iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these&#xD;
      interventions and strategies have been often disappointing or inconclusive and intravenous&#xD;
      volume expansion remains the only therapy of undisputed efficacy.&#xD;
&#xD;
      Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's&#xD;
      hydration status, and can be performed at the bedside within minutes [Maioli, JACC&#xD;
      1014;63:1387-94]. In this study we defined patients with &quot;lower fluid status&quot; with high risk&#xD;
      of CI-AKI (Male with resistance/height ratio &gt; 315 Ohm/meter and Female &gt; 380 Ohm/meter).&#xD;
      BIVA may represent the optimal tool to monitor the adequacy of volume expansion and&#xD;
      protective strategy delivery.&#xD;
&#xD;
      However, most hydration protocols rely on a &quot;one size fits all&quot; approach with a fixed volume&#xD;
      and time of infusion without an assessment of whether adequate hydration was achieved. This&#xD;
      practice risks either under-hydration without true amelioration of CI-AKI risk or&#xD;
      over-hydration with risk of adverse outcomes.&#xD;
&#xD;
      Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 4</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of contrast-induced acute kidney injury</measure>
    <time_frame>1 day</time_frame>
    <description>contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of contrast medium</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse clinical events</measure>
    <time_frame>1 month</time_frame>
    <description>adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of contrast-induced acute kidney injury</measure>
    <time_frame>2 days</time_frame>
    <description>Contrast-induced acute kidney injury defined as an increase in serum creatinine &gt;= 0.3 mg/dl over baseline value within 2 days after the administration of contrast medium</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">296</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Standard saline infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double saline infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium chloride infusion</intervention_name>
    <arm_group_label>Double saline infusion</arm_group_label>
    <arm_group_label>Standard saline infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive patients admitted in Cardiology Unit for coronary or peripheral&#xD;
             angiography with &quot;lower fluid status&quot; defined on the basis bio-impedance analysis&#xD;
             (Male with resistance/height ratio &gt; 315 Ohm/meter and Female &gt; 380 Ohm/meter).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contrast medium administration within the 10 days&#xD;
&#xD;
          -  end stage renal failure requiring dialysis&#xD;
&#xD;
          -  refused to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Maioli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale S. Stefano - Prato - Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale Santo Stefano</name>
      <address>
        <city>Prato</city>
        <zip>59100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.</citation>
    <PMID>24530668</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>October 15, 2015</last_update_submitted>
  <last_update_submitted_qc>October 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale Misericordia e Dolce</investigator_affiliation>
    <investigator_full_name>Mauro Maioli</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Contrast-induced nephropathy</keyword>
  <keyword>Contrast-Induced acute kidney injury</keyword>
  <keyword>Contrast media</keyword>
  <keyword>Angiography</keyword>
  <keyword>Coronary percutaneous intervention</keyword>
  <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/NCT02225431
org study id: Prato0706
secondary id: 2013/1
nct id: NCT02225431
lead sponsor: 
has dmc: Yes
The aim of this study was to evaluate, in patients with "lower fluid status" defined by
      bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are
      associated with different volume expansion and differing risks for CI-AKI in patients
      undergoing coronary angiographic procedures.
Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in
      patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute
      kidney injury, CI-AKI).

      Several protocols have been tested for the prevention of CI-AKI, including periprocedural
      hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or
      iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these
      interventions and strategies have been often disappointing or inconclusive and intravenous
      volume expansion remains the only therapy of undisputed efficacy.

      Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's
      hydration status, and can be performed at the bedside within minutes [Maioli, JACC
      1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk
      of CI-AKI (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).
      BIVA may represent the optimal tool to monitor the adequacy of volume expansion and
      protective strategy delivery.

      However, most hydration protocols rely on a "one size fits all" approach with a fixed volume
      and time of infusion without an assessment of whether adequate hydration was achieved. This
      practice risks either under-hydration without true amelioration of CI-AKI risk or
      over-hydration with risk of adverse outcomes.

      Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Incidence of contrast-induced acute kidney injury
time frame: 1 day
description: contrast acute kidney injury is defined as an increase in serum Cystatin C concentration 10% above the baseline value at 24 hours after administration of contrast medium
measure: Adverse clinical events
time frame: 1 month
description: adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
measure: Incidence of contrast-induced acute kidney injury
time frame: 2 days
description: Contrast-induced acute kidney injury defined as an increase in serum creatinine >= 0.3 mg/dl over baseline value within 2 days after the administration of contrast medium
arm group label: Standard saline infusion
arm group type: Active Comparator
description: All patients received standard intravenous saline hydration (0.9% sodium chloride, 1 ml/kg/h for 12 hours before and after procedure)
arm group label: Double saline infusion
arm group type: Experimental
description: All patients received double dose of intravenous saline hydration (0.9% sodium chloride, 2 ml/kg/h for 12 hours before and after procedure)
intervention type: Drug
intervention name: sodium chloride infusion
arm group label: Double saline infusion
arm group label: Standard saline infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mauro Maioli, MD
role: Principal Investigator
affiliation: Ospedale S. Stefano - Prato - Italy
facility: 
country: Italy
citation: Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C. Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury. J Am Coll Cardiol. 2014 Apr 15;63(14):1387-94. doi: 10.1016/j.jacc.2014.01.025. Epub 2014 Feb 12.
PMID: 24530668
responsible party type: Principal Investigator
investigator affiliation: Ospedale Misericordia e Dolce
investigator full name: Mauro Maioli
investigator title: MD
mesh term: Acute Kidney Injury