xml: <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/NCT06041737</url>
    </required_header>
    <id_info>
      <org_study_id>2023/0023</org_study_id>
      <nct_id>NCT06041737</nct_id>
    </id_info>
    <brief_title>Determination of a Profile of Patients With Renal Failure to be Educated as a Priority in Order to Avoid Emergency Hospitalizations</brief_title>
    <acronym>DETERPROFIPA</acronym>
    <official_title>Determination of a Profile of Patients With Renal Failure to be Educated as a Priority in Order to Avoid Emergency Hospitalizations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Sud Francilien</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Sud Francilien</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 purpose of this study is to map the population of stage 4 and 5 kidney failure patients&#xD;
        followed in consultation by the CHSF nephrology team and to determine the factors associated&#xD;
        with recurrent hospitalizations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This observational study on retrospective data does not justify a specific calculation of&#xD;
        numbers. Over the 27-month observation period, have been identified in the department an&#xD;
        active file of approximately 440 stage 4 or 5 chronic kidney failure patients eligible for&#xD;
        the study.&#xD;
  &#xD;
        The qualitative variables will be expressed in numbers and corresponding percentages, and&#xD;
        compared by Fisher's exact test. Quantitative variables will be expressed by their mean and&#xD;
        standard deviation or by their median and interquartiles, depending on their distribution.&#xD;
        They will be compared by the Student test in the case of a normal distribution, by the&#xD;
        Wilcoxon test otherwise.&#xD;
  &#xD;
        The main outcome criterion, namely the occurrence of hospitalization during the observation&#xD;
        period, will be analyzed using a logistic regression model. The covariates tested in the&#xD;
        model will be :&#xD;
  &#xD;
          -  Age&#xD;
  &#xD;
          -  Gender&#xD;
  &#xD;
          -  Helpers among: Parent, Sibling, Child, Spouse, neighbors, friend, Social care (social&#xD;
             security (SSC), mutual insurance or universal health coverage (CMU)&#xD;
  &#xD;
          -  Active, disabled, retired&#xD;
  &#xD;
          -  MRC Stage (4 or 5) in 2020&#xD;
  &#xD;
          -  Mode of entry into nephrology consultation (after hospitalization in Nephrology,&#xD;
             attending physician, diabetologist, cardiologist, other)&#xD;
  &#xD;
          -  History and associated comorbidities including high blood pressure, diabetes,&#xD;
             dyslipidemia, vascular pathologies, heart disease, sleep apnea syndrome, obesity, other&#xD;
             chronic pathologies.&#xD;
  &#xD;
          -  Number of chronic pathologies of the patient&#xD;
  &#xD;
          -  The pathology(s) retained by the nephrologist as responsible for the kidney disease&#xD;
             (several pathologies can be retained and reported as such)&#xD;
  &#xD;
          -  Number of treatments on the patient's prescription&#xD;
  &#xD;
          -  Treatments: hypotensive, antidiabetic, hypolipidemic, diuretic, potassium chelator,&#xD;
             cardiac treatment, antithrombotics, others&#xD;
  &#xD;
          -  Number of years of follow-up in nephrology at the CHSF before the period studied.&#xD;
  &#xD;
          -  Status of known patients at the end of follow-up (it can be before 03/31/2022 if the&#xD;
             patient has moved to another status before) among: consultation, dialysis (urgent or&#xD;
             normal), transplant, death, lost to follow-up .&#xD;
  &#xD;
          -  Did the patient benefit from pre-dialysis information, at what Glomerular Filtration&#xD;
             Rate (GFR) and what was his choice (peritoneal dialysis, hemodialysis or conservative&#xD;
             treatment)&#xD;
  &#xD;
          -  Did the patient benefit from an arteriovenous fistula, at what GFR&#xD;
  &#xD;
          -  Did the patient benefit from a pre-transplant assessment&#xD;
  &#xD;
          -  The number of consultations by a nephrologist, in consultation or in day hospital.&#xD;
  &#xD;
          -  The number of consultations canceled by the patient.&#xD;
  &#xD;
          -  The number of consultations not honored by the patient.&#xD;
  &#xD;
          -  Le nombre de consultations sans bilan récent.&#xD;
  &#xD;
          -  The GFR at the consultation&#xD;
  &#xD;
          -  Unscheduled hospitalizations at the CHSF during follow-up, whether in nephrology or in&#xD;
             another hospital department.&#xD;
  &#xD;
          -  The reason(s) for unscheduled hospitalizations related to renal pathology (cardiac&#xD;
             decompensation, anemia, sodium and water overdose, acute lung edema (APO), high blood&#xD;
             pressure (hypertension), emergency dialysis starts, renal failure acute (ARI), and ionic&#xD;
             disorders,)&#xD;
  &#xD;
          -  The number of days for each hospitalization. The log-linearity of the quantitative&#xD;
             variables will be evaluated by graphical method. In the event of non-log-linearity, the&#xD;
             variable will be discretized according to its median or according to the inflection&#xD;
             points of the curve. Covariates whose unadjusted Odds Ratio has a p value less than 0.20&#xD;
             will be retained in the multivariate model. All second-order interactions will be&#xD;
             tested. Multicollinearity phenomena will be evaluated by measuring variance inflation&#xD;
             factors, with a positivity threshold set at 2.5. A variable selection using a descending&#xD;
             step-by-step method minimizing the Akaiké criterion will then be carried out. The area&#xD;
             under the ROC curve of the final model as well as the p value of the Hosmer-Lemeshow&#xD;
             test will be specified.&#xD;
  &#xD;
        In secondary analyses, patients who were not hospitalized during the observation period will&#xD;
        be compared to those who had 1 to 3 hospitalizations and to those who had 4 or more&#xD;
        hospitalizations. Qualitative variables will be analyzed using Fisher's exact test. The&#xD;
        quantitative variables will be compared by analysis of variance if its conditions of&#xD;
        application are met, by the Kruskal-Wallis test otherwise. In the event of significance,&#xD;
        comparisons 2 by 2 will be carried out, respectively by the Student test or the Wilcoxon&#xD;
        test, with adjustment of the value of p by the Bonferroni-Holm correction in order to take&#xD;
        account of the multiple comparisons.&#xD;
  &#xD;
        All the tests will be carried out bilaterally, with a 1st type risk set at 5%. The analysis&#xD;
        will be performed using R software (version 4.3.1 © 2023 The R Foundation for Statistical&#xD;
        Computing).&#xD;
  &#xD;
        Management of missing data:&#xD;
  &#xD;
        no plan to replace missing data for this observational data study, the design of which in any&#xD;
        case makes the presence of missing data in numbers unlikely, particularly concerning the main&#xD;
        criterion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Determination of factors associated with recurrent hospitalizations in patients followed for stage 4 or 5 Chronic Renal Failure.</measure>
      <time_frame>at day 0</time_frame>
      <description>characteristics of patients who have had at least one hospitalization and those who have never been hospitalized over the period from January 1, 2020 to March 31, 2022</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mapping of the population of patients with stage IV and V renal failure followed in consultation by the CHSF nephrology team.</measure>
      <time_frame>at day 0</time_frame>
      <description>General and medical characteristics of patients followed at the CHSF in nephrology consultation for stage 4 or 5 CKD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determination of the profile(s) of stage 4 or 5 CKD patients with recurrent hospitalizations.</measure>
      <time_frame>at day 0</time_frame>
      <description>Comparison of patient cohorts with a single hospitalization and more than 4 hospitalizations</description>
    </secondary_outcome>
    <enrollment type="Anticipated">447</enrollment>
    <condition>Stage 4 or 5 Renal Failure</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>consultation</intervention_name>
      <description>nephrology consultation during 2020</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with renal insufficiency in stage 4 or 5 having had at least one nephrology&#xD;
          consultation at the CHSF during the year 2020.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients&#xD;
  &#xD;
            -  patients with stage 4 or 5 kidney failure who had at least one nephrology consultation&#xD;
               during 2020.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Patients informed of the study who objected to the collection of their data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Christine BOUHELIER, nurse</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier Sud Francilien</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christine BOUHELIER, nurse</last_name>
      <phone>01 61 69 50 38</phone>
      <email>christine.bouhelier@chsf.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Caroline TOURTE</last_name>
      <phone>01 61 69 31 20</phone>
      <email>caroline.tourte@chsf.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre Hospitalier Sud Francilien</name>
        <address>
          <city>Corbeil-essonnes Cedex</city>
          <zip>91106</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Caroline TOURTE</last_name>
        <phone>0161693730</phone>
        <email>caroline.tourte@chsf.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</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 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic kidney disease</keyword>
    <keyword>Patients profile</keyword>
    <keyword>Hospitalization profile</keyword>
    <keyword>Advanced practice nurse</keyword>
    <keyword>Organizational protocol</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041737
  org study id: 2023/0023
  nct id: NCT06041737
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to map the population of stage 4 and 5 kidney failure patients
        followed in consultation by the CHSF nephrology team and to determine the factors associated
        with recurrent hospitalizations.
  This observational study on retrospective data does not justify a specific calculation of
        numbers. Over the 27-month observation period, have been identified in the department an
        active file of approximately 440 stage 4 or 5 chronic kidney failure patients eligible for
        the study.
  
        The qualitative variables will be expressed in numbers and corresponding percentages, and
        compared by Fisher's exact test. Quantitative variables will be expressed by their mean and
        standard deviation or by their median and interquartiles, depending on their distribution.
        They will be compared by the Student test in the case of a normal distribution, by the
        Wilcoxon test otherwise.
  
        The main outcome criterion, namely the occurrence of hospitalization during the observation
        period, will be analyzed using a logistic regression model. The covariates tested in the
        model will be :
  
          -  Age
  
          -  Gender
  
          -  Helpers among: Parent, Sibling, Child, Spouse, neighbors, friend, Social care (social
             security (SSC), mutual insurance or universal health coverage (CMU)
  
          -  Active, disabled, retired
  
          -  MRC Stage (4 or 5) in 2020
  
          -  Mode of entry into nephrology consultation (after hospitalization in Nephrology,
             attending physician, diabetologist, cardiologist, other)
  
          -  History and associated comorbidities including high blood pressure, diabetes,
             dyslipidemia, vascular pathologies, heart disease, sleep apnea syndrome, obesity, other
             chronic pathologies.
  
          -  Number of chronic pathologies of the patient
  
          -  The pathology(s) retained by the nephrologist as responsible for the kidney disease
             (several pathologies can be retained and reported as such)
  
          -  Number of treatments on the patient's prescription
  
          -  Treatments: hypotensive, antidiabetic, hypolipidemic, diuretic, potassium chelator,
             cardiac treatment, antithrombotics, others
  
          -  Number of years of follow-up in nephrology at the CHSF before the period studied.
  
          -  Status of known patients at the end of follow-up (it can be before 03/31/2022 if the
             patient has moved to another status before) among: consultation, dialysis (urgent or
             normal), transplant, death, lost to follow-up .
  
          -  Did the patient benefit from pre-dialysis information, at what Glomerular Filtration
             Rate (GFR) and what was his choice (peritoneal dialysis, hemodialysis or conservative
             treatment)
  
          -  Did the patient benefit from an arteriovenous fistula, at what GFR
  
          -  Did the patient benefit from a pre-transplant assessment
  
          -  The number of consultations by a nephrologist, in consultation or in day hospital.
  
          -  The number of consultations canceled by the patient.
  
          -  The number of consultations not honored by the patient.
  
          -  Le nombre de consultations sans bilan récent.
  
          -  The GFR at the consultation
  
          -  Unscheduled hospitalizations at the CHSF during follow-up, whether in nephrology or in
             another hospital department.
  
          -  The reason(s) for unscheduled hospitalizations related to renal pathology (cardiac
             decompensation, anemia, sodium and water overdose, acute lung edema (APO), high blood
             pressure (hypertension), emergency dialysis starts, renal failure acute (ARI), and ionic
             disorders,)
  
          -  The number of days for each hospitalization. The log-linearity of the quantitative
             variables will be evaluated by graphical method. In the event of non-log-linearity, the
             variable will be discretized according to its median or according to the inflection
             points of the curve. Covariates whose unadjusted Odds Ratio has a p value less than 0.20
             will be retained in the multivariate model. All second-order interactions will be
             tested. Multicollinearity phenomena will be evaluated by measuring variance inflation
             factors, with a positivity threshold set at 2.5. A variable selection using a descending
             step-by-step method minimizing the Akaiké criterion will then be carried out. The area
             under the ROC curve of the final model as well as the p value of the Hosmer-Lemeshow
             test will be specified.
  
        In secondary analyses, patients who were not hospitalized during the observation period will
        be compared to those who had 1 to 3 hospitalizations and to those who had 4 or more
        hospitalizations. Qualitative variables will be analyzed using Fisher's exact test. The
        quantitative variables will be compared by analysis of variance if its conditions of
        application are met, by the Kruskal-Wallis test otherwise. In the event of significance,
        comparisons 2 by 2 will be carried out, respectively by the Student test or the Wilcoxon
        test, with adjustment of the value of p by the Bonferroni-Holm correction in order to take
        account of the multiple comparisons.
  
        All the tests will be carried out bilaterally, with a 1st type risk set at 5%. The analysis
        will be performed using R software (version 4.3.1 © 2023 The R Foundation for Statistical
        Computing).
  
        Management of missing data:
  
        no plan to replace missing data for this observational data study, the design of which in any
        case makes the presence of missing data in numbers unlikely, particularly concerning the main
        criterion.
  observational model: Cohort
  time perspective: Retrospective
  measure: Determination of factors associated with recurrent hospitalizations in patients followed for stage 4 or 5 Chronic Renal Failure.
  time frame: at day 0
  description: characteristics of patients who have had at least one hospitalization and those who have never been hospitalized over the period from January 1, 2020 to March 31, 2022
  measure: Mapping of the population of patients with stage IV and V renal failure followed in consultation by the CHSF nephrology team.
  time frame: at day 0
  description: General and medical characteristics of patients followed at the CHSF in nephrology consultation for stage 4 or 5 CKD
  measure: Determination of the profile(s) of stage 4 or 5 CKD patients with recurrent hospitalizations.
  time frame: at day 0
  description: Comparison of patient cohorts with a single hospitalization and more than 4 hospitalizations
  intervention type: Other
  intervention name: consultation
  description: nephrology consultation during 2020
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Christine BOUHELIER, nurse
  role: Principal Investigator
  affiliation: Centre Hospitalier Sud Francilien
  last name: Christine BOUHELIER, nurse
  phone: 01 61 69 50 38
  email: christine.bouhelier@chsf.fr
  last name: Caroline TOURTE
  phone: 01 61 69 31 20
  email: caroline.tourte@chsf.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Renal Insufficiency
  mesh term: Emergencies
  sharing ipd: No