<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/NCT04444765</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/19/0496</org_study_id>
    <nct_id>NCT04444765</nct_id>
  </id_info>
  <brief_title>Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis in Critically Ill Patients</brief_title>
  <acronym>COOBrA</acronym>
  <official_title>Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with&#xD;
      increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal&#xD;
      replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT&#xD;
      worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and&#xD;
      bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with&#xD;
      acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with&#xD;
      hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the&#xD;
      circulation during IHD (HCO3- &lt;--&gt; CO2 + H2O). Some recent studies showed that acetate free&#xD;
      biofiltration (AFB-K), a technique that does not require dialysate acidification, could be&#xD;
      associated with better hemodynamic stability and to a lower amount of CO2 delivered to the&#xD;
      patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent&#xD;
      RRT in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational study, investigators aim to characterize the hemodynamic&#xD;
      and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurence of hemodynamic event</measure>
    <time_frame>From admission to discharge, up to 4 hours</time_frame>
    <description>The occurrence of at least one of the following events will be considered a hemodynamic event :&#xD;
Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively)&#xD;
Tachycardia (increase of heart beating ≥ 20%)&#xD;
Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation)&#xD;
Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring)&#xD;
Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in maximal PaCO2</measure>
    <time_frame>1 hour after the beginning of dialysis , up to 4 hours</time_frame>
    <description>Evaluation of PaCO2 by arterial blood gas test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum difference of tcPCO2 and etCO2</measure>
    <time_frame>From admission to discharge, up to 4 hours</time_frame>
    <description>Evaluation of TcPCO2 and etCO2 by trans-cutaneous measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the &quot;strong ion difference&quot;</measure>
    <time_frame>baseline, 4 hours</time_frame>
    <description>Evaluation of the &quot;strong ion difference&quot; by blood ionogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plasma pH</measure>
    <time_frame>1 hour after the beginning of dialysis session, up to 4 hours</time_frame>
    <description>Evaluation of plasma pH by blood ionogram</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Patients with bicarbonate-based intermittent dialysis</arm_group_label>
    <description>Dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with acetate free biofiltration dialysis</arm_group_label>
    <description>Acetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of clinical and biological data during renal replacement therapy sessions</intervention_name>
    <description>Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).</description>
    <arm_group_label>Patients with acetate free biofiltration dialysis</arm_group_label>
    <arm_group_label>Patients with bicarbonate-based intermittent dialysis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute kidney injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
          -  Invasive monitoring of blood pressure&#xD;
&#xD;
          -  Non opposition to the research&#xD;
&#xD;
          -  Admission to the intensive care unit&#xD;
&#xD;
          -  Need of intermittent hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sodium bicarbonate infusion&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Juridical protection&#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>Stanislas Faguer, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute kidney injury</keyword>
  <keyword>renal replacement therapy</keyword>
  <keyword>acetate free biofiltration</keyword>
  <keyword>bicarbonate-based hemodialysis</keyword>
  <keyword>C02 removal</keyword>
  <keyword>intensive care unit</keyword>
  <keyword>critical care</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/NCT04444765
org study id: RC31/19/0496
nct id: NCT04444765
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with
      increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal
      replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT
      worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and
      bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with
      acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with
      hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the
      circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free
      biofiltration (AFB-K), a technique that does not require dialysate acidification, could be
      associated with better hemodynamic stability and to a lower amount of CO2 delivered to the
      patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent
      RRT in critically ill patients.
In this prospective observational study, investigators aim to characterize the hemodynamic
      and respiratory tolerances of HDI-bicar and AFB-K in critically ill patients requiring RRT.
observational model: Case-Only
time perspective: Prospective
measure: Occurence of hemodynamic event
time frame: From admission to discharge, up to 4 hours
description: The occurrence of at least one of the following events will be considered a hemodynamic event :
Hypotension (decrease of systolic or mean blood pressures ≥ 15 and ≥ 10% respectively)
Tachycardia (increase of heart beating ≥ 20%)
Cardiac arrythmia (junctional tachycardia, atrial fibrillation, flutter, ventricular tachycardia or fibrillation)
Decrease of the cardiac output ≥ 15% (only in patients with invasive cardiac output monitoring)
Starting (or increase dosing) of norepinephrine ≥ 0.1 µg/kg/min
measure: Change in maximal PaCO2
time frame: 1 hour after the beginning of dialysis , up to 4 hours
description: Evaluation of PaCO2 by arterial blood gas test
measure: Maximum difference of tcPCO2 and etCO2
time frame: From admission to discharge, up to 4 hours
description: Evaluation of TcPCO2 and etCO2 by trans-cutaneous measurement
measure: Change in the "strong ion difference"
time frame: baseline, 4 hours
description: Evaluation of the "strong ion difference" by blood ionogram
measure: Change in plasma pH
time frame: 1 hour after the beginning of dialysis session, up to 4 hours
description: Evaluation of plasma pH by blood ionogram
arm group label: Patients with bicarbonate-based intermittent dialysis
description: Dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid).
arm group label: Patients with acetate free biofiltration dialysis
description: Acetate free biofiltration (AFB-K)is a technique that does not require dialysate acidification
intervention type: Other
intervention name: Collection of clinical and biological data during renal replacement therapy sessions
description: Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).
arm group label: Patients with acetate free biofiltration dialysis
arm group label: Patients with bicarbonate-based intermittent dialysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stanislas Faguer, MD
role: Principal Investigator
facility: 
country: France
responsible party type: Sponsor
mesh term: Acute Kidney Injury