<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/NCT04452539</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB_GENDERPED</org_study_id>
    <nct_id>NCT04452539</nct_id>
  </id_info>
  <brief_title>Gender Influence on Morbi-mortality in Pediatric Cardiac Surgery.</brief_title>
  <official_title>Gender Influence on Mortality and Major Morbidity After Pediatric Cardiac Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brugmann University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      Recent studies show an important influence of gender on inflammatory reactions. Cardiac&#xD;
      surgery is associated with a major systemic inflammatory response. The investigators want to&#xD;
      evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gender plays an important role in the inflammatory response. This is due to hormonal&#xD;
      influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear&#xD;
      facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass,&#xD;
      is associated with a major inflammatory response. This response is even more marked in&#xD;
      pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on&#xD;
      mortality and major morbidity in paediatric patients undergoing cardiac surgery. The&#xD;
      investigators will do a retrospective cohort study, analysing the local database of all&#xD;
      paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any&#xD;
      difference in mortality and /or major morbidity according to gender.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The investigators will use a propensity score on 11 pre-operative variables clinically judged&#xD;
      relevant. Both group will be matched until a absolute standardised difference &lt; 15% is&#xD;
      obtained. This type of matching, contrary to a P value, is independent of sample size.&#xD;
      Variables will be presented as mean, standard deviation or percentage for frequency&#xD;
      distributions. After propensity score matching, logistic regressions will be performed on&#xD;
      binary variables and linear regressions on continuous variables. A Bonferroni correction will&#xD;
      be used for multiple comparisons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 30, 2020</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>Mortality</measure>
    <time_frame>Beginning of the operation until 5 days postop</time_frame>
    <description>Mortality in paediatric cardiac surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>Beginning of the operation until 5 days postop</time_frame>
    <description>Major morbidity in paediatric cardiac surgery, defined as at least 2 of the following conditions: Respiratory failure (mechanical ventilation &gt; 90h), prolonged inotropic support (&gt; 5 mcg/kg/min of dobutamine for more than 48h postop), renal insufficiency (Drop in glomerular filtration rate &gt; 75% compared to preop values)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Pediatric Cardiac Surgery</condition>
  <condition>Gender</condition>
  <arm_group>
    <arm_group_label>Paediatric cardiac surgery patients</arm_group_label>
    <description>All patients undergoing paediatric cardiac surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paediatric cardiac surgery</intervention_name>
    <description>All patients undergoing paediatric cardiac surgery</description>
    <arm_group_label>Paediatric cardiac surgery patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing paediatric cardiac surgery with cardiopulmonary bypas at our&#xD;
        institution from jan 2006 to dec 2019.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing paediatric cardiac surgery with cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Jehova's witness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Denis Schmartz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Universitaire des Enfants Reine Fabiola</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>January 27, 2021</last_update_submitted>
  <last_update_submitted_qc>January 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Denis SCHMARTZ</investigator_full_name>
    <investigator_title>Head, Department of Anesthesiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04452539
org study id: CHUB_GENDERPED
nct id: NCT04452539
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recent studies show an important influence of gender on inflammatory reactions. Cardiac
      surgery is associated with a major systemic inflammatory response. The investigators want to
      evaluate the gender influence on morbi-mortality in pediatric cardiac surgery patients.
Gender plays an important role in the inflammatory response. This is due to hormonal
      influences, but also different genetic regulation of pro-inflammatory cytokines, as nuclear
      facto kapp B. it is also know that cardiac surgery, especially under cardiopulmonary bypass,
      is associated with a major inflammatory response. This response is even more marked in
      pediatric cardiac surgery. The investigators hypothesise that there is a gender influence on
      mortality and major morbidity in paediatric patients undergoing cardiac surgery. The
      investigators will do a retrospective cohort study, analysing the local database of all
      paediatric cardiac surgery cases from jan 2006 to dec 2019. Primary outcome will be any
      difference in mortality and /or major morbidity according to gender.

      Statistical analysis:

      The investigators will use a propensity score on 11 pre-operative variables clinically judged
      relevant. Both group will be matched until a absolute standardised difference < 15% is
      obtained. This type of matching, contrary to a P value, is independent of sample size.
      Variables will be presented as mean, standard deviation or percentage for frequency
      distributions. After propensity score matching, logistic regressions will be performed on
      binary variables and linear regressions on continuous variables. A Bonferroni correction will
      be used for multiple comparisons.
observational model: Cohort
time perspective: Retrospective
measure: Mortality
time frame: Beginning of the operation until 5 days postop
description: Mortality in paediatric cardiac surgery
measure: Morbidity
time frame: Beginning of the operation until 5 days postop
description: Major morbidity in paediatric cardiac surgery, defined as at least 2 of the following conditions: Respiratory failure (mechanical ventilation > 90h), prolonged inotropic support (> 5 mcg/kg/min of dobutamine for more than 48h postop), renal insufficiency (Drop in glomerular filtration rate > 75% compared to preop values)
arm group label: Paediatric cardiac surgery patients
description: All patients undergoing paediatric cardiac surgery
intervention type: Procedure
intervention name: Paediatric cardiac surgery
description: All patients undergoing paediatric cardiac surgery
arm group label: Paediatric cardiac surgery patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
last name: Denis Schmartz, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Denis SCHMARTZ
investigator title: Head, Department of Anesthesiology
sharing ipd: No