<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/NCT03763188</url>
  </required_header>
  <id_info>
    <org_study_id>AGros</org_study_id>
    <nct_id>NCT03763188</nct_id>
  </id_info>
  <brief_title>Dialysis Weaning in Intensive Care Units (Dialysis STOP)</brief_title>
  <acronym>D-STOP</acronym>
  <official_title>Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Alexandre Gros</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gros, Alexandre, M.D.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in&#xD;
      Intensive Care Units.&#xD;
&#xD;
      The objective is to show that remove the dialysis catheter, once daily urinary urea excretion&#xD;
      is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis&#xD;
      catheters, and thus without dialysis, the first 28 days after insertion.&#xD;
&#xD;
      Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy&#xD;
      withdrawal criterion, according to a recent French study (citations). A rate greater than&#xD;
      1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. This criterion is&#xD;
      influenced by the use of diuretics, and is easily accessible and achievable. Daily urinary&#xD;
      urea excretion is representative of the recovery of renal function. The French study&#xD;
      establishing this new withdrawal criterion was monocentric and retrospective. However, we&#xD;
      changed our practices as soon as we became aware of them.&#xD;
&#xD;
      French multicentric (Bordeaux University Hospital, Libourne, Pau and Bayonne Hospitals)&#xD;
      study, before and after:&#xD;
&#xD;
        -  Period before: patients who were dialysed in the intensive care units of Bordeaux,&#xD;
           Libourne, Pau and Bayonne, from November 2013 to November 2015.&#xD;
&#xD;
        -  Period after: patients selected prospectively in the 4 hospitals.&#xD;
&#xD;
      When diuresis &gt; 100 ml/d, an urinary ionogram is realized daily. Measurement of urinary urea&#xD;
      excretion every day. Ablation of the catheter as soon as daily urinary urinary excretion &gt;&#xD;
      1.35 mmol/kg/d.&#xD;
&#xD;
      Measurement of daily urinary excretion the following 3 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the catheter free days</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>new dialysis catheter and new renal replacement therapy</measure>
    <time_frame>the first 7 days after dialysis catheter ablation</time_frame>
    <description>number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of dialysis catheter laid per patients</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>median</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of renal replacement therapy</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dialysis catheters infections</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ICU stay</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at at day 28</measure>
    <time_frame>the first 28 days after catheter insertion</time_frame>
    <description>number</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">260</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>the group BEFORE</arm_group_label>
    <description>Retrospective group. The daily urinary urea excretion was unknown.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the group AFTER</arm_group_label>
    <description>Prospective group. Use the daily urinary urea excretion to guide the renal replacement therapy weaning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Use of daily urinary urea excretion</intervention_name>
    <description>Weaning dialysis catheter</description>
    <arm_group_label>the group AFTER</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients &gt; 18 years of age, admitted to intensive care unit, who have a RRT for AKI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt; 18 of age, who have a Renal Replacement Therapy, in intensive care&#xD;
             unit,&#xD;
&#xD;
          -  with a diuresis &gt; 100 ml/d.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients still presenting &quot;hard&quot; criteria for RRT: metabolic acidosis with pH &lt; 7.15&#xD;
             and PCO2 &lt;50mmHg; acute pulmonary edema (&gt; 5l 02 or 50% FiO2 for Sp02 &gt; 95%)&#xD;
             objectified by echocardiography; K&gt; 5.5 mmol/l after treatment&#xD;
&#xD;
          -  Renal transplantation&#xD;
&#xD;
          -  Long-term chronic kidney injury or short-term dialysis project (arteriovenous fistula&#xD;
             created).&#xD;
&#xD;
          -  Acute Kidney Injury secondary to thrombotic microangiopathy&#xD;
&#xD;
          -  Acute Kidney Injury secondary to an obstacle even if dialysed&#xD;
&#xD;
          -  RRT started for toxic cause without IRA (lithium,...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alexandre Gros</name>
      <address>
        <city>Bordeaux</city>
        <state>Aquitaine</state>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Aniort J, Ait Hssain A, Pereira B, Coupez E, Pioche PA, Leroy C, Heng AE, Souweine B, Lautrette A. Daily urinary urea excretion to guide intermittent hemodialysis weaning in critically ill patients. Crit Care. 2016 Feb 19;20:43. doi: 10.1186/s13054-016-1225-5.</citation>
    <PMID>26895760</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>March 15, 2020</last_update_submitted>
  <last_update_submitted_qc>March 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Gros, Alexandre, M.D.</investigator_affiliation>
    <investigator_full_name>Dr Alexandre Gros</investigator_full_name>
    <investigator_title>GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator</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>
  <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/NCT03763188
org study id: AGros
nct id: NCT03763188
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in
      Intensive Care Units.

      The objective is to show that remove the dialysis catheter, once daily urinary urea excretion
      is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis
      catheters, and thus without dialysis, the first 28 days after insertion.

      Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).
Daily urinary excretion of urea may provide a safe and reproducible renal replacement therapy
      withdrawal criterion, according to a recent French study (citations). A rate greater than
      1.35 mmol/kg/d would predict a weaning success of 97.1% at 1 week. This criterion is
      influenced by the use of diuretics, and is easily accessible and achievable. Daily urinary
      urea excretion is representative of the recovery of renal function. The French study
      establishing this new withdrawal criterion was monocentric and retrospective. However, we
      changed our practices as soon as we became aware of them.

      French multicentric (Bordeaux University Hospital, Libourne, Pau and Bayonne Hospitals)
      study, before and after:

        -  Period before: patients who were dialysed in the intensive care units of Bordeaux,
           Libourne, Pau and Bayonne, from November 2013 to November 2015.

        -  Period after: patients selected prospectively in the 4 hospitals.

      When diuresis > 100 ml/d, an urinary ionogram is realized daily. Measurement of urinary urea
      excretion every day. Ablation of the catheter as soon as daily urinary urinary excretion >
      1.35 mmol/kg/d.

      Measurement of daily urinary excretion the following 3 days.
observational model: Cohort
time perspective: Other
measure: the catheter free days
time frame: the first 28 days after catheter insertion
description: days
measure: new dialysis catheter and new renal replacement therapy
time frame: the first 7 days after dialysis catheter ablation
description: number
measure: number of dialysis catheter laid per patients
time frame: the first 28 days after catheter insertion
description: median
measure: Duration of renal replacement therapy
time frame: the first 28 days after catheter insertion
description: days
measure: Renal therapy replacement complications (hemorrhage, heparin-induced thrombocytopenia, other)
time frame: the first 28 days after catheter insertion
description: number
measure: Dialysis catheters infections
time frame: the first 28 days after catheter insertion
description: number
measure: Duration of ICU stay
time frame: the first 28 days after catheter insertion
description: days
measure: Duration of mechanical ventilation
time frame: the first 28 days after catheter insertion
description: days
measure: Mortality at at day 28
time frame: the first 28 days after catheter insertion
description: number
arm group label: the group BEFORE
description: Retrospective group. The daily urinary urea excretion was unknown.
arm group label: the group AFTER
description: Prospective group. Use the daily urinary urea excretion to guide the renal replacement therapy weaning.
intervention type: Other
intervention name: Use of daily urinary urea excretion
description: Weaning dialysis catheter
arm group label: the group AFTER
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Aniort J, Ait Hssain A, Pereira B, Coupez E, Pioche PA, Leroy C, Heng AE, Souweine B, Lautrette A. Daily urinary urea excretion to guide intermittent hemodialysis weaning in critically ill patients. Crit Care. 2016 Feb 19;20:43. doi: 10.1186/s13054-016-1225-5.
PMID: 26895760
responsible party type: Sponsor-Investigator
investigator affiliation: Gros, Alexandre, M.D.
investigator full name: Dr Alexandre Gros
investigator title: GROS, Alexandre, Medical Doctor, Intensive Care Unit, Principal Investigator
mesh term: Acute Kidney Injury
sharing ipd: No