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/NCT05970952</url>
    </required_header>
    <id_info>
      <org_study_id>82-2023</org_study_id>
      <nct_id>NCT05970952</nct_id>
    </id_info>
    <brief_title>Acute Kidney Injury in Intensive Care Patients</brief_title>
    <acronym>AKI-ICU</acronym>
    <official_title>Incidence, Risk Factors, and Outcomes for Acute Kidney Injury in Intensive Care Patients: a Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Haseki Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Haseki Training and Research Hospital</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>
        The goal of this prospective observational study is to evaluate the incidence, risk factors,&#xD;
        and outcomes for development of acute kidney injury (AKI) in intensive care pateints.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  What is the incidence of acute kidney injury in intensive care patients?&#xD;
  &#xD;
          -  What are risk factors for development of acute kidney injury? All adult patients&#xD;
             admitted to the ICU with a stay of 48 h or more will be included in the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Material Methods:&#xD;
  &#xD;
        Study design and setting: This study is designed as an prospective observational clinical&#xD;
        trial to investigate incidence, causes, risk factors and outcome of AKI in critically ill&#xD;
        patients. It will be performed in the medical-surgical ICU with 50 beds of the Health Science&#xD;
        University Haseki Research and Training Hospital, a referral hospital with 700 beds in&#xD;
        Istanbul, Turkey. It will be carried out according to the Declaration of Helsinki with the&#xD;
        approval of the local Institutional Review Board (Date/number: 26 April 2023/82) and informed&#xD;
        consent will be obtained from all patients or their family members.&#xD;
  &#xD;
        Patients selection: All adult patients admitted to the ICU with a stay of 48 h or more will&#xD;
        be included in the study. Patients with missing data, end-stage renal disease, existence of&#xD;
        AKI at the time of ICU admission or history of renal transplantation will be excluded from&#xD;
        the study. Patients that were readmitted to the ICU within 48 h will reunited with the first&#xD;
        admission and be considered as one admission for the analysis. The follow-up period is&#xD;
        limited to 28 days.&#xD;
  &#xD;
        Data collection: In enrolled patients data on demographic characteristics (age, sex, height,&#xD;
        weight, body mass index) will be obtained. Lengths of stay (LOSs) in the ICU and hospital,&#xD;
        main reason for ICU admittance, co-morbid conditions, organ failures developed during ICU&#xD;
        stay and presence of contrast exposure will be recorded as well as data on mechanical&#xD;
        ventilation, renal replacement therapies and invasive procedures including central venous&#xD;
        line placement, arterial line placement and tracheostomy. Laboratory test results including&#xD;
        blood count, coagulation parameters, blood biochemistry parameters and arterial blood gases&#xD;
        will be collected daily along with urine analysis, urinary output and fluid balance. Data on&#xD;
        drugs including vasoactive, inotropic, corticosteroid, diuretic, antiinfective agents will be&#xD;
        noted daily. Blood and blood components transfusions will also be recorded. Moreover presence&#xD;
        and duration of hypotension (mean arterial pressure &lt;70 mmHg) and rhythm disorders will be&#xD;
        recorded. Severity of illness will be evaluated by using Acute Physiology and Chronic Health&#xD;
        Evaluation (APACHE) II scores at the time of ICU admission.&#xD;
  &#xD;
        Outcomes and definitions: The primary outcome variable of the study is to detect the&#xD;
        incidence of AKI. The diagnosis and classification of AKI will be performed according to the&#xD;
        KDIGO criteria based on changes in serum creatinine (SCr) or urine output.31 If available,&#xD;
        SCr value measured within a 3-month period prior to ICU admission will be defined as baseline&#xD;
        value. If no such value existed, SCr value at the time of admission to the ICU will be&#xD;
        considered as baseline value. CKD will be defined as an estimated glomerular filtration rate&#xD;
        (eGFR) less than 60 ml/min/1.73m2 computed by using MDRD equation according to the KDIGO&#xD;
        recommendations.31 Secondary outcome variables included all-cause mortality, clinical and&#xD;
        laboratory risk factors for the development of AKI as described above.&#xD;
  &#xD;
        Statistical analysis: Statistical analysis was performed using the SPSS software package for&#xD;
        Windows (Statistical Package for Social Sciences, version 22.0; SPSS Inc., Chicago, Illinois,&#xD;
        USA). In the power analysis based on previous studies, it was calculated that at least 159&#xD;
        patients should be included in the study for 0.05 type 1 error and 80% power. Descriptive&#xD;
        statistics will given as numbers and percentages for categorical variables or as the mean ±&#xD;
        standard deviation and median (minimum-maximum) for numeric variables. Multiple logistic&#xD;
        regression analysis will be used to estimate odds ratio for risk factors to development of&#xD;
        AKI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">November 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 24, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To assess the incidence of acute kidney injury in ICU patients</measure>
      <time_frame>Up to 28 day</time_frame>
      <description>During their management lasting more than 48 hours in the ICU, some patients develop acute kidney injury.</description>
    </primary_outcome>
    <enrollment type="Anticipated">159</enrollment>
    <condition>Acute Renal Injury</condition>
    <condition>Critical Illness</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The patients who developed acute kidney inhury during intensive care unit stay.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All adult patients admitted to the ICU with a stay of 48 h or more&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with missing data, end-stage renal disease, existence of AKI at the time of&#xD;
               ICU admission or history of renal transplantation will be excluded from the study.&#xD;
               Patients that were readmitted to the ICU within 48 h will reunited with the first&#xD;
               admission and be considered as one admission for the analysis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sinan Uzman, Assoc. prof.</last_name>
      <role>Study Director</role>
      <affiliation>Health Science Unibersity, Haseki Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sinan Uzman, Assoc. prof.</last_name>
      <phone>+905055645271</phone>
      <email>drsinanuzman@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Health Science University, Haseki Training and Research Hospital</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sinan Uzman, Assoc. prof.</last_name>
        <phone>+9050555645271</phone>
        <email>drsinanuzman@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>acute renal injury</keyword>
    <keyword>intensive care unit</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Kidney Injury</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT05970952
  org study id: 82-2023
  nct id: NCT05970952
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective observational study is to evaluate the incidence, risk factors,
        and outcomes for development of acute kidney injury (AKI) in intensive care pateints.
  
        The main questions it aims to answer are:
  
          -  What is the incidence of acute kidney injury in intensive care patients?
  
          -  What are risk factors for development of acute kidney injury? All adult patients
             admitted to the ICU with a stay of 48 h or more will be included in the study.
  Material Methods:
  
        Study design and setting: This study is designed as an prospective observational clinical
        trial to investigate incidence, causes, risk factors and outcome of AKI in critically ill
        patients. It will be performed in the medical-surgical ICU with 50 beds of the Health Science
        University Haseki Research and Training Hospital, a referral hospital with 700 beds in
        Istanbul, Turkey. It will be carried out according to the Declaration of Helsinki with the
        approval of the local Institutional Review Board (Date/number: 26 April 2023/82) and informed
        consent will be obtained from all patients or their family members.
  
        Patients selection: All adult patients admitted to the ICU with a stay of 48 h or more will
        be included in the study. Patients with missing data, end-stage renal disease, existence of
        AKI at the time of ICU admission or history of renal transplantation will be excluded from
        the study. Patients that were readmitted to the ICU within 48 h will reunited with the first
        admission and be considered as one admission for the analysis. The follow-up period is
        limited to 28 days.
  
        Data collection: In enrolled patients data on demographic characteristics (age, sex, height,
        weight, body mass index) will be obtained. Lengths of stay (LOSs) in the ICU and hospital,
        main reason for ICU admittance, co-morbid conditions, organ failures developed during ICU
        stay and presence of contrast exposure will be recorded as well as data on mechanical
        ventilation, renal replacement therapies and invasive procedures including central venous
        line placement, arterial line placement and tracheostomy. Laboratory test results including
        blood count, coagulation parameters, blood biochemistry parameters and arterial blood gases
        will be collected daily along with urine analysis, urinary output and fluid balance. Data on
        drugs including vasoactive, inotropic, corticosteroid, diuretic, antiinfective agents will be
        noted daily. Blood and blood components transfusions will also be recorded. Moreover presence
        and duration of hypotension (mean arterial pressure <70 mmHg) and rhythm disorders will be
        recorded. Severity of illness will be evaluated by using Acute Physiology and Chronic Health
        Evaluation (APACHE) II scores at the time of ICU admission.
  
        Outcomes and definitions: The primary outcome variable of the study is to detect the
        incidence of AKI. The diagnosis and classification of AKI will be performed according to the
        KDIGO criteria based on changes in serum creatinine (SCr) or urine output.31 If available,
        SCr value measured within a 3-month period prior to ICU admission will be defined as baseline
        value. If no such value existed, SCr value at the time of admission to the ICU will be
        considered as baseline value. CKD will be defined as an estimated glomerular filtration rate
        (eGFR) less than 60 ml/min/1.73m2 computed by using MDRD equation according to the KDIGO
        recommendations.31 Secondary outcome variables included all-cause mortality, clinical and
        laboratory risk factors for the development of AKI as described above.
  
        Statistical analysis: Statistical analysis was performed using the SPSS software package for
        Windows (Statistical Package for Social Sciences, version 22.0; SPSS Inc., Chicago, Illinois,
        USA). In the power analysis based on previous studies, it was calculated that at least 159
        patients should be included in the study for 0.05 type 1 error and 80% power. Descriptive
        statistics will given as numbers and percentages for categorical variables or as the mean ±
        standard deviation and median (minimum-maximum) for numeric variables. Multiple logistic
        regression analysis will be used to estimate odds ratio for risk factors to development of
        AKI.
  observational model: Cohort
  time perspective: Prospective
  measure: To assess the incidence of acute kidney injury in ICU patients
  time frame: Up to 28 day
  description: During their management lasting more than 48 hours in the ICU, some patients develop acute kidney injury.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Sinan Uzman, Assoc. prof.
  role: Study Director
  affiliation: Health Science Unibersity, Haseki Training and Research Hospital
  last name: Sinan Uzman, Assoc. prof.
  phone: +905055645271
  email: drsinanuzman@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Critical Illness
  mesh term: Wounds and Injuries