<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/NCT01682590</url>
  </required_header>
  <id_info>
    <org_study_id>Quenot IDEAL-ICU</org_study_id>
    <nct_id>NCT01682590</nct_id>
  </id_info>
  <brief_title>I.D.E.A.L.-I.C.U. (Initiation of Dialysis EArly Versus deLayed in Intensive Care Unit)</brief_title>
  <acronym>IDEAL-ICU</acronym>
  <official_title>Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this multicentric, randomized controlled trial is to assess whether the timing&#xD;
      of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90&#xD;
      days in patients with severe acute kidney injury at the failure stage (according to RIFLE&#xD;
      criteria) during the initial phase of septic shock.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute renal failure is one of the most feared complications of septic shock and occurs in 51%&#xD;
      of patients with these conditions. Mortality at 3 months ranges from 36% to 60%. To date,&#xD;
      these exists no consensus regarding the optimal time to initiate renal remplacement therapy&#xD;
      (RRT). Retrospective and observational studies have suggested that early initiation of RRT&#xD;
      could help to improve prognosis in these patients. Therefore, we aim to investigate wether&#xD;
      early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at&#xD;
      the &quot;failure&quot; stage according to the RIFLE Criteria), will reduce 90-day mortality as&#xD;
      compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care&#xD;
      unit (ICU) patients with septic shock who develop acute renal failure.&#xD;
&#xD;
      Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 et&#xD;
      360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay&#xD;
      and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will&#xD;
      be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in&#xD;
      terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension,&#xD;
      hemorrhagic complications, and dependence on RRT at hospital discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the&quot;failure&quot; stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT(48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>90 days</time_frame>
    <description>To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the &quot;failure&quot; stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the tolerance and evaluation quality of life</measure>
    <time_frame>90 days</time_frame>
    <description>Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 and 360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension, hemorrhagic complications, and dependence on RRT at hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Septic Shock</condition>
  <condition>Acute Renal Failure (as Defined by the &quot;Failure&quot; Stage of the RIFLE Classification)</condition>
  <arm_group>
    <arm_group_label>Early initiation of RRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start of RRT within a maximum of 12 hours after randomisation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deferred RRT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Start of RRT between 48 and 60 hours after randomisation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal Remplacement Therapy</intervention_name>
    <description>Investigators of each center will have the choice of the RRT technique based on their usual practice: intermittent hemodialysis, intermittent hemodiafiltration, continuous hemodialysis, continuous hemofiltration, continuous hemodiafiltration (typically the continuous techniques in the acute phase, followed by intermittent techniques after stabilization).&#xD;
In case of life threatening conditions within the 48 hours after randomisation (hyperkalemia, metabolic acidosis or pulmonary edema) the RRT will be initiated as soon as possible.&#xD;
In case of improvement of renal function within the 48 hours after randomisation (defined as the return of spontaneous urine output &gt; 1000ml/24 hr or &gt;2000ml/24hr with diuretics), RRT is not mandatory.</description>
    <arm_group_label>Deferred RRT</arm_group_label>
    <arm_group_label>Early initiation of RRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults (males or females, age &gt;18 years) with septic shock who develop acute renal failure&#xD;
        (as defined by the &quot;Failure&quot; stage of the RIFLE classification) will be eligible for&#xD;
        inclusion.&#xD;
&#xD;
        Septic shock is defined as severe sepsis with at least 2 to 4 &quot;SIRS&quot; criteria and&#xD;
        persistent hypotension despite adequate vascular filling and need vaso-active drugs.&#xD;
&#xD;
        SIRS is defined as the simultaneous presence of at least 2 of the following criteria :&#xD;
&#xD;
          -  Body temperature ≥ 38°C ou ≤ 36°C&#xD;
&#xD;
          -  Heart rate ≥ 90 bpm&#xD;
&#xD;
          -  Respiratory rate ≥ 20/mn or PaCO2 ≤ 32 mmHg&#xD;
&#xD;
          -  Leucocytes ≥ 12,000/mm3 or ≤ 4,000/mm3 or &gt;10% immature forms.&#xD;
&#xD;
        Acute renal insufficiency is defined as the &quot;failure&quot; stage of the RIFLE classification,&#xD;
        i.e. the presence of at least one of the following criteria:&#xD;
&#xD;
          -  Increased creatinine x 3 times the baseline value&#xD;
&#xD;
          -  Oliguria &lt; 0.3 ml/kg/h for 12 hours&#xD;
&#xD;
          -  Anuria (diuresis &lt; 100ml) for at least 12 hours&#xD;
&#xD;
        All patients are required to provide informed consent after having been appropriately&#xD;
        informed about the study. In case of temporary incapacity of the patient to sign, the&#xD;
        consent form can be signed by a surrogate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients presenting any of the following criteria will not be eligible for inclusion in the&#xD;
        study:&#xD;
&#xD;
          1. Patients with chronic renal at dialysis.&#xD;
&#xD;
          2. Patients presenting acute renal failure of type obstructive and patients already&#xD;
             presenting emergency criteria for immediate hemodialysis at the time of randomization&#xD;
             (i.e. hyperkalemia &gt;6.5 mmol/L or pH&lt;7.15 or pulmonary oedema by fluid overload)&#xD;
&#xD;
          3. Patients already had hemodialysis before their arrival in the intensive care unit&#xD;
&#xD;
          4. Pregnant women.&#xD;
&#xD;
          5. Moribund patients whose life expectancy is less than 24 hours&#xD;
&#xD;
          6. Patients unlikely to survive to 28 days because of uncontrollable comorbidities (e.g.&#xD;
             cardiac, pulmonary or hepatic disease at the terminal stage, hepatorenal syndrome,&#xD;
             uncontrolled cancer, severe post-anorexic encephalopathy…)&#xD;
&#xD;
          7. Patients with advance directives indicating their wish not to be resuscitated.&#xD;
&#xD;
          8. Patients under legal guardianship.&#xD;
&#xD;
          9. Patients participing in another interventional study that may influence the prognosis&#xD;
             of patients.&#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>Jean-Pierre QUENOT</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Universitaire Dijon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saber Davide BARBAR</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nimes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Avignon</name>
      <address>
        <city>Avignon</city>
        <zip>84000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Belfort</name>
      <address>
        <city>Belfort</city>
        <zip>90000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de BOURG-EN-BRESSE</name>
      <address>
        <city>Bourg-en-Bresse</city>
        <zip>01012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <zip>14003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Dieppe</name>
      <address>
        <city>Dieppe</city>
        <zip>76200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Sud Essonne - Site Etampes</name>
      <address>
        <city>Etampes</city>
        <zip>91 150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Raymond-Poincaré GARCHES (AP-HP)</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de LA ROCHE sur YON</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier de l'institut Catholique de LILLE</name>
      <address>
        <city>Lille</city>
        <zip>59160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHG Mulhouse</name>
      <address>
        <city>Mulhouse</city>
        <zip>68100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy Brabois</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nîmes</name>
      <address>
        <city>Nîmes</city>
        <zip>30000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Orléans</name>
      <address>
        <city>Orleans</city>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPITAL BICHAT Claude-Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Périgueux</name>
      <address>
        <city>Périgueux</city>
        <zip>24019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg - Nouvel hôpital civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Metz</name>
      <address>
        <city>Thionville</city>
        <zip>57100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Barbar SD, Binquet C, Monchi M, Bruyere R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.</citation>
    <PMID>24998258</PMID>
  </reference>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>septic shock; acute renal failure; renal remplacement therapy; mortality; intensive care; critical care; acute kidney injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Shock</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/NCT01682590
org study id: Quenot IDEAL-ICU
nct id: NCT01682590
lead sponsor: 
has dmc: Yes
The purpose of this multicentric, randomized controlled trial is to assess whether the timing
      of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90
      days in patients with severe acute kidney injury at the failure stage (according to RIFLE
      criteria) during the initial phase of septic shock.
Acute renal failure is one of the most feared complications of septic shock and occurs in 51%
      of patients with these conditions. Mortality at 3 months ranges from 36% to 60%. To date,
      these exists no consensus regarding the optimal time to initiate renal remplacement therapy
      (RRT). Retrospective and observational studies have suggested that early initiation of RRT
      could help to improve prognosis in these patients. Therefore, we aim to investigate wether
      early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at
      the "failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as
      compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care
      unit (ICU) patients with septic shock who develop acute renal failure.

      Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 et
      360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay
      and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will
      be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in
      terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension,
      hemorrhagic complications, and dependence on RRT at hospital discharge.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the"failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT(48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure
primary purpose: Other
masking: None (Open Label)
measure: Progression free survival
time frame: 90 days
description: To investigate whether early initiation of RRT (within 12 hours after a diagnosis of acute renal insufficiency at the "failure" stage according to the RIFLE Criteria), will reduce 90-day mortality as compared to deferred initiation of RRT (48 to 60 hours after diagnosis), in intensive care unit (ICU) patients with septic shock who develop acute renal failure.
measure: Comparison of the tolerance and evaluation quality of life
time frame: 90 days
description: Secondary objectives include: to compare the impact of the two RRT strategies on 28, 180 and 360 day mortality, duration of mechanical ventilation, duration of RRT, duration of ICU stay and duration of overall hospital stay. In addition, quality of life at 90 and 360 days will be evaluated using the EQ5D questionnaire. Tolerance of both strategies will be compared in terms of metabolic disorders, arrhythmias, pulmonary oedema by overload, hypotension, hemorrhagic complications, and dependence on RRT at hospital discharge.
arm group label: Early initiation of RRT
arm group type: Experimental
description: Start of RRT within a maximum of 12 hours after randomisation.
arm group label: Deferred RRT
arm group type: Active Comparator
description: Start of RRT between 48 and 60 hours after randomisation.
intervention type: Procedure
intervention name: Renal Remplacement Therapy
description: Investigators of each center will have the choice of the RRT technique based on their usual practice: intermittent hemodialysis, intermittent hemodiafiltration, continuous hemodialysis, continuous hemofiltration, continuous hemodiafiltration (typically the continuous techniques in the acute phase, followed by intermittent techniques after stabilization).
In case of life threatening conditions within the 48 hours after randomisation (hyperkalemia, metabolic acidosis or pulmonary edema) the RRT will be initiated as soon as possible.
In case of improvement of renal function within the 48 hours after randomisation (defined as the return of spontaneous urine output > 1000ml/24 hr or >2000ml/24hr with diuretics), RRT is not mandatory.
arm group label: Deferred RRT
arm group label: Early initiation of RRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Pierre QUENOT
role: Study Director
affiliation: Centre Hospitalier Universitaire Dijon
last name: Saber Davide BARBAR
role: Principal Investigator
affiliation: CHU de Nimes
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country: France
citation: Barbar SD, Binquet C, Monchi M, Bruyere R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.
PMID: 24998258
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Acute Kidney Injury
mesh term: Renal Insufficiency
mesh term: Shock