<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/NCT03302624</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-351</org_study_id>
    <nct_id>NCT03302624</nct_id>
  </id_info>
  <brief_title>Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU</brief_title>
  <acronym>SURIA</acronym>
  <official_title>A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <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) involves poor prognosis in ICU patients. The renal prognosis at&#xD;
      long term is unknown.&#xD;
&#xD;
      The study will determine chronic kidney injury incidence and quality of life, five years&#xD;
      after AK during ICU stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can&#xD;
      be enrolled in SURIA.&#xD;
&#xD;
      Patients are contacted by telephone. Investigator delivery objective and honest information.&#xD;
      If patients accepts the study, answers will be collected.&#xD;
&#xD;
      Collected data are: creatinine serum, two surveys (quality of life and activities of daily&#xD;
      living), date of onset of renal replacement therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2017</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>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>severity of CKD according to the International Classification of Chronic Kidney Disease</measure>
    <time_frame>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>impact of the renal replacement therapy on long-term renal function</measure>
    <time_frame>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>Quality of life will be assessed with the Q5D score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living</measure>
    <time_frame>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>Activities of daily living will be assessed with the Katz adjustment scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 years after the first acute kidney injury requiring renal replacement therapy</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">506</enrollment>
  <condition>Acute Kidney Injuries</condition>
  <condition>Quality of Life</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>Renal Replacement Therapy</condition>
  <arm_group>
    <arm_group_label>Patients who were included in ELVIS study</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        ICU patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ICU Patients included in ELVIS study, AKI requiring renal replacement therapy Length of ICU&#xD;
        stay ≥ 48h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnant or nursing woman's job&#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>Alexandre LAUTRETTE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>0473751195</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alexandre LAUTRETTE</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Didier GRUSON</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elie AZOULAY</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kada KLOUCHE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent ARGAUD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien BOHE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cedric BRUEL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christophe MARIAT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yves COHEN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-Michel CONSTANTIN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carole SCHWEBEL</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute kidney injury</keyword>
  <keyword>quality of life</keyword>
  <keyword>Renal replacement therapy</keyword>
  <keyword>Intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03302624
org study id: CHU-351
nct id: NCT03302624
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at
      long term is unknown.

      The study will determine chronic kidney injury incidence and quality of life, five years
      after AK during ICU stay.
Prospective study. All patients who participated ELVIS study (clinical trials: 00875069) can
      be enrolled in SURIA.

      Patients are contacted by telephone. Investigator delivery objective and honest information.
      If patients accepts the study, answers will be collected.

      Collected data are: creatinine serum, two surveys (quality of life and activities of daily
      living), date of onset of renal replacement therapy.
observational model: Cohort
time perspective: Prospective
measure: incidence of chronic kidney disease
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: incidence of chronic kidney disease in patients who had an acute kidney injury during their ICU stay and requiring an renal replacement therapy
measure: severity of CKD according to the International Classification of Chronic Kidney Disease
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: Kidney function will be measured by creatinine serum or chronic dialysis or kidney transplantation
measure: impact of the renal replacement therapy on long-term renal function
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: Intermittent or continuous renal replacement therapy. Data collected in the database from ELVIS study. Kidney function will be measured by creatinine serum or chronic dialysis
measure: quality of life
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: Quality of life will be assessed with the Q5D score
measure: Activities of daily living
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: Activities of daily living will be assessed with the Katz adjustment scales
measure: Mortality
time frame: 5 years after the first acute kidney injury requiring renal replacement therapy
description: Mortality
arm group label: Patients who were included in ELVIS study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre LAUTRETTE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 0473751195
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries