<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/NCT03767049</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)101/2012</org_study_id>
    <nct_id>NCT03767049</nct_id>
  </id_info>
  <brief_title>Readmissions of Lung Transplant Patients in ICU.</brief_title>
  <official_title>Readmissions of Lung Transplant Patients in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Salud Carlos III</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</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>
      A multi-centre, prospective and observational study was carried out from August 2012 to June&#xD;
      2016 in five Spanish tertiary-care university hospitals with well-established lung transplant&#xD;
      programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre&#xD;
      (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba).&#xD;
&#xD;
      The study population comprised all consecutive adult lung transplant recipients who required&#xD;
      ICUr (after &gt;7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr&#xD;
      period).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</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>Causes of ICU readmission in LT adults</measure>
    <time_frame>Augist 1. 2012 - June 30, 2016</time_frame>
    <description>To assess the principal causes of ICU readmission in LT adults.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictors of ICU and hospital mortality.</measure>
    <time_frame>Augist 1. 2012 - June 30, 2016</time_frame>
    <description>To identify potential predictors of ICU and hospital mortality.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">153</enrollment>
  <condition>Lung Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>Lung transplant patients readmitted in ICU</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colection of clinical data</intervention_name>
    <description>Colection of clinical data</description>
    <arm_group_label>Lung transplant patients readmitted in ICU</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Lung transplant recipients who required ICU readmission.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive adult lung transplant recipients who required ICU readmission (after&#xD;
             &gt;7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr&#xD;
             period).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ICU readmission &lt; 8 days post-transplant discharge from ICU.&#xD;
&#xD;
          -  ICU readmission for early postoperative care following lung transplantation.&#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>Cristopher Alan Mazo Torre, MD</last_name>
    <role>Study Chair</role>
    <affiliation>0</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03767049
org study id: PR(AG)101/2012
nct id: NCT03767049
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multi-centre, prospective and observational study was carried out from August 2012 to June
      2016 in five Spanish tertiary-care university hospitals with well-established lung transplant
      programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre
      (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba).

      The study population comprised all consecutive adult lung transplant recipients who required
      ICUr (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr
      period).
observational model: Cohort
time perspective: Prospective
measure: Causes of ICU readmission in LT adults
time frame: Augist 1. 2012 - June 30, 2016
description: To assess the principal causes of ICU readmission in LT adults.
measure: Predictors of ICU and hospital mortality.
time frame: Augist 1. 2012 - June 30, 2016
description: To identify potential predictors of ICU and hospital mortality.
arm group label: Lung transplant patients readmitted in ICU
intervention type: Other
intervention name: Colection of clinical data
description: Colection of clinical data
arm group label: Lung transplant patients readmitted in ICU
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cristopher Alan Mazo Torre, MD
role: Study Chair
affiliation: 0
responsible party type: Sponsor
sharing ipd: Undecided