<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/NCT03791606</url>
  </required_header>
  <id_info>
    <org_study_id>KLin</org_study_id>
    <nct_id>NCT03791606</nct_id>
  </id_info>
  <brief_title>Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU)</brief_title>
  <acronym>PRECISE-ICU</acronym>
  <official_title>Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention at Intensive Care Unit：a Single-center Cohort Study(PRECISE-ICU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiyang Lin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Provincial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A retrospective, observational study included all consecutively critically ill patients&#xD;
      undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian&#xD;
      Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the&#xD;
      incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill&#xD;
      patients undergoing PCI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>CI-AKI</measure>
    <time_frame>1 year</time_frame>
    <description>an absolute SCr increase ≥0.3 mg/dL or a relative increase in SCr ≥50% within 48 hours of contrast medium exposure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>in-hospital adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>congestive heart failure [CHF], bleeding, stroke, reinfarction, stent thrombosis, required renal replacement therapy, length of hospital stay, hospital costs, and mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MACEs for long-term follow up</measure>
    <time_frame>1 year</time_frame>
    <description>mortality,stent restenosis, recurrent myocardial infarction, target vessel revascularization,stroke,bleeding,required renal replacement therapy</description>
  </other_outcome>
  <enrollment type="Actual">755</enrollment>
  <condition>CIN</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All Critically ill patients undergoing PCI at ICU were enrolled&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients undergoing PCI at ICU&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  end-stage renal disease (eGFR &lt;15 mL/min/1.73 m2)&#xD;
&#xD;
          -  long-term dialysis treatment&#xD;
&#xD;
          -  intravascular administration of contrast medium within the last 7 or 3 days&#xD;
             postoperatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fujian Provincial</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Kaiyang Lin</investigator_full_name>
    <investigator_title>Fujian Provincial Hospital</investigator_title>
  </responsible_party>
  <!-- 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/NCT03791606
org study id: KLin
nct id: NCT03791606
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A retrospective, observational study included all consecutively critically ill patients
      undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian
      Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the
      incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill
      patients undergoing PCI.
observational model: Cohort
time perspective: Retrospective
measure: CI-AKI
time frame: 1 year
description: an absolute SCr increase ≥0.3 mg/dL or a relative increase in SCr ≥50% within 48 hours of contrast medium exposure
measure: in-hospital adverse events
time frame: 1 year
description: congestive heart failure [CHF], bleeding, stroke, reinfarction, stent thrombosis, required renal replacement therapy, length of hospital stay, hospital costs, and mortality
measure: MACEs for long-term follow up
time frame: 1 year
description: mortality,stent restenosis, recurrent myocardial infarction, target vessel revascularization,stroke,bleeding,required renal replacement therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Kaiyang Lin
investigator title: Fujian Provincial Hospital