<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/NCT03282409</url>
  </required_header>
  <id_info>
    <org_study_id>AOR16089</org_study_id>
    <nct_id>NCT03282409</nct_id>
  </id_info>
  <brief_title>Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit</brief_title>
  <acronym>PREDICT</acronym>
  <official_title>Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 study aims to develop and validate a prediction score of chronic renal disease occurrence&#xD;
      within 3 years after ICU discharge in patients who suffered an acute kidney failure during&#xD;
      ICU stay and recovered normal renal function at 90 days following their discharge.&#xD;
&#xD;
      The primary study outcome is the incidence of chronic renal disease within the first 3 years&#xD;
      after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60&#xD;
      mL/minute/1.73m2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As second objectives, the study aims to:&#xD;
&#xD;
        -  Evaluate the GFR decline in patients who had an underlying chronic kidney disease.&#xD;
&#xD;
        -  Evaluate factors associated with a persistent decreased GFR at day-90.&#xD;
&#xD;
        -  Characterization the clinical and biological phenotype of chronic renal disease in these&#xD;
           patients.&#xD;
&#xD;
        -  Evaluate treatments provided to these patients according to CKD occurence.&#xD;
&#xD;
        -  Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.&#xD;
&#xD;
        -  Assess the quality of life every year for 3 years.&#xD;
&#xD;
        -  Evaluate the medico-economic burden of CKD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">February 2025</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>Incidence of chronic kidney disease</measure>
    <time_frame>At 3 years</time_frame>
    <description>Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression of chronic renal disease defined by the slope of GFR decline</measure>
    <time_frame>At 3 years</time_frame>
    <description>For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by a GFR decline greater than 30% at 3 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of the proteinuria</measure>
    <time_frame>At 3 years</time_frame>
    <description>Evolution of urinary protein to creatinine ratio (mg/mmol).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation</measure>
    <time_frame>At 3 years</time_frame>
    <description>For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by need to dialysis, or need a renal transplantation, and GFR &lt; 15mL/minute/1.73m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of cardiovascular events and thromboembolic events</measure>
    <time_frame>At 3 years</time_frame>
    <description>Cardiovascular events include acute coronary syndrome, ischemic stroke, peripheral artery disease, ventricular rhythm disorder and sudden death.&#xD;
Thromboembolic events included deep vein thrombosis and pulmonary embolism.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>At 3 years</time_frame>
    <description>All-cause mortality and cardiovascular cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>At the end of 1 year</time_frame>
    <description>Assessment of quality of life of patients by the scale KDQOL-SF-12. The SF-12 is a short form that includes Items 1-12 as generic core of kidney Disease Quality of Life Instrument (KDQOL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>At the end of 1 year</time_frame>
    <description>Assessment of quality of life of patients by the scale EQ-5D-5L. The EQ-5D-5L questionnaire consists the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>At 3 years</time_frame>
    <description>Costs related to medical care</description>
  </secondary_outcome>
  <enrollment type="Actual">425</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Chronic Renal Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with acute kidney injury during ICU stay&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ⩾ 18 years;&#xD;
&#xD;
          -  Patient suffering an acute kidney injury (defined by AKIN score ⩾1) during ICU stay;&#xD;
&#xD;
          -  Patient discharged alive from the ICU;&#xD;
&#xD;
          -  Patient's signed consent obtained;&#xD;
&#xD;
          -  Patient covered by a healthcare insurance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding woman;&#xD;
&#xD;
          -  SOFA score &lt; 1 (except for kidney assessment) at time of ICU admission;&#xD;
&#xD;
          -  End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU&#xD;
             admission;&#xD;
&#xD;
          -  Patient treated with dialysis at ICU discharge;&#xD;
&#xD;
          -  Immunosuppressive treatment prior to ICU admission;&#xD;
&#xD;
          -  Patient under legal incapacity (tutor or guardian protection);&#xD;
&#xD;
          -  Being unable to follow-up of the study;&#xD;
&#xD;
          -  Life expectancy expected shorter than 90 days;&#xD;
&#xD;
          -  Refusal to participate in the study;&#xD;
&#xD;
          -  Patient's main address is outside of Il de France region for the centers in this&#xD;
             region;&#xD;
&#xD;
          -  Patient &lt; 18 years;&#xD;
&#xD;
          -  Patient not affiliated to national social security scheme;&#xD;
&#xD;
          -  Patient deprived of liberty by judicial measure.&#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>Guillaume Geri, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine Vieillard Baron, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive care unit, Ambroise Pare Hospital</name>
      <address>
        <city>Boulogne Billancourt</city>
        <state>Hauts-de-seine</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prediction</keyword>
  <keyword>Chronic Renal Disease</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03282409
org study id: AOR16089
nct id: NCT03282409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to develop and validate a prediction score of chronic renal disease occurrence
      within 3 years after ICU discharge in patients who suffered an acute kidney failure during
      ICU stay and recovered normal renal function at 90 days following their discharge.

      The primary study outcome is the incidence of chronic renal disease within the first 3 years
      after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60
      mL/minute/1.73m2.
As second objectives, the study aims to:

        -  Evaluate the GFR decline in patients who had an underlying chronic kidney disease.

        -  Evaluate factors associated with a persistent decreased GFR at day-90.

        -  Characterization the clinical and biological phenotype of chronic renal disease in these
           patients.

        -  Evaluate treatments provided to these patients according to CKD occurence.

        -  Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.

        -  Assess the quality of life every year for 3 years.

        -  Evaluate the medico-economic burden of CKD.
observational model: Cohort
time perspective: Prospective
measure: Incidence of chronic kidney disease
time frame: At 3 years
description: Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.
measure: Progression of chronic renal disease defined by the slope of GFR decline
time frame: At 3 years
description: For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by a GFR decline greater than 30% at 3 years.
measure: Progression of the proteinuria
time frame: At 3 years
description: Evolution of urinary protein to creatinine ratio (mg/mmol).
measure: Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation
time frame: At 3 years
description: For patients who have chronic renal disease history and developped an acute kidney failure during ICU stay, progression of chronic renal disease defined by need to dialysis, or need a renal transplantation, and GFR < 15mL/minute/1.73m2.
measure: Occurrence of cardiovascular events and thromboembolic events
time frame: At 3 years
description: Cardiovascular events include acute coronary syndrome, ischemic stroke, peripheral artery disease, ventricular rhythm disorder and sudden death.
Thromboembolic events included deep vein thrombosis and pulmonary embolism.
measure: All-cause mortality
time frame: At 3 years
description: All-cause mortality and cardiovascular cause mortality
measure: Quality of life assessment
time frame: At the end of 1 year
description: Assessment of quality of life of patients by the scale KDQOL-SF-12. The SF-12 is a short form that includes Items 1-12 as generic core of kidney Disease Quality of Life Instrument (KDQOL).
measure: Quality of life assessment
time frame: At the end of 1 year
description: Assessment of quality of life of patients by the scale EQ-5D-5L. The EQ-5D-5L questionnaire consists the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state.
measure: Cost
time frame: At 3 years
description: Costs related to medical care
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Geri, MD, PhD
role: Principal Investigator
affiliation: Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
last name: Antoine Vieillard Baron, MD, PhD
role: Study Director
affiliation: Service de Réanimation médico-chirurgicale, Hôpital Ambroise Paré
facility: 
country: France
responsible party type: Sponsor
mesh term: Acute Kidney Injury
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
mesh term: Wounds and Injuries
sharing ipd: No