<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/NCT03253861</url>
  </required_header>
  <id_info>
    <org_study_id>RC16_0126</org_study_id>
    <nct_id>NCT03253861</nct_id>
  </id_info>
  <brief_title>PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis</brief_title>
  <acronym>PancRea</acronym>
  <official_title>Risk Factors and Outcomes of Infected Pancreatic Necrosis: Retrospective Cohort of 148 Patients Admitted to the ICU for Acute Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes 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>
      Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is&#xD;
      associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta&#xD;
      classification differentiates mild, moderate, and severe acute pancreatitis, and each of&#xD;
      these categories correlates with morbidity and mortality. Mortality remains high, between 10%&#xD;
      and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30%&#xD;
      of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is&#xD;
      a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to&#xD;
      remove the infected intra-abdominal material, preferably using minimally invasive techniques&#xD;
      such as percutaneous and endoscopic drainage, which have been proven beneficial. In several&#xD;
      studies biological markers such as procalcitonin and interleukin 8 were effective in&#xD;
      predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying&#xD;
      risk factors may help to improve standardized strategies for early diagnosis and treatment,&#xD;
      and then patients outcome. Our primary objective was to identify risk factors for IPN in&#xD;
      patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe&#xD;
      the management and outcomes of IPN&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using electronic patient data monitoring systems, the investigators reviewed all patients&#xD;
      with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity&#xD;
      or ICUs at the Nantes University Hospital, from January 1, 2012, to december 31, 2015. For&#xD;
      enrolled patients, general clinical characteristics were collected. Patients were categorized&#xD;
      into two groups according to the development of an infected pancreatic necrosis (highly&#xD;
      suspected or proven), and the differences of these characteristics between two groups were&#xD;
      evaluated. Potential risk factors were collected and studied by using multiple logistic&#xD;
      regression analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk factors of infected pancreatic necrosis</measure>
    <time_frame>4 months</time_frame>
    <description>Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors of mortality</measure>
    <time_frame>4 months</time_frame>
    <description>Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (mortality). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of non-survival</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">148</enrollment>
  <condition>Acute Necrotizing Pancreatitis</condition>
  <condition>Infection</condition>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>control patients</arm_group_label>
    <description>patients without an infected pancreatic necrosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case patients</arm_group_label>
    <description>patients with an infected pancreatic necrosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Case patients</arm_group_label>
    <arm_group_label>control patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with acute necrotizing pancreatitis admitted in an ICU between January 2012&#xD;
        and December 2015 for moderately severe or severe acute pancreatitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age &gt;18 years) with acute necrotizing pancreatitis admitted in an ICU&#xD;
             between January 2012 and December 2015 for moderately severe or severe acute&#xD;
             pancreatitis were included.&#xD;
&#xD;
          -  Organ failure that resolves within 48 h (transient organ failure) and/or local or&#xD;
             systemic complications without persistent organ failure or persistent organ failure&#xD;
             (&gt;48 h)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mild acute pancreatitis, defined as no organ failure or local complication (No&#xD;
             necrosis or peri-pancreatic collection)&#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>Charlotte Garret, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes CHU</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute necrotizing pancreatitis</keyword>
  <keyword>Acute pancreatitis</keyword>
  <keyword>Sepsis/complications</keyword>
  <keyword>Infection</keyword>
  <keyword>Organ Dysfunction Scores</keyword>
  <keyword>Drainage</keyword>
  <keyword>Catheters</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Multiresistant organism</keyword>
  <keyword>Pancreatitis/complications</keyword>
  <keyword>Pancreatitis/diagnosis</keyword>
  <keyword>Pancreatitis/surgery</keyword>
  <keyword>Pancreatitis/therapy</keyword>
  <keyword>Pancreatitis, Acute Necrotizing/complications</keyword>
  <keyword>Pancreatitis, Acute Necrotizing/surgery</keyword>
  <keyword>Pancreatitis, Acute Necrotizing/therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Acute Necrotizing</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03253861
org study id: RC16_0126
nct id: NCT03253861
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is
      associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta
      classification differentiates mild, moderate, and severe acute pancreatitis, and each of
      these categories correlates with morbidity and mortality. Mortality remains high, between 10%
      and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30%
      of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is
      a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to
      remove the infected intra-abdominal material, preferably using minimally invasive techniques
      such as percutaneous and endoscopic drainage, which have been proven beneficial. In several
      studies biological markers such as procalcitonin and interleukin 8 were effective in
      predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying
      risk factors may help to improve standardized strategies for early diagnosis and treatment,
      and then patients outcome. Our primary objective was to identify risk factors for IPN in
      patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe
      the management and outcomes of IPN
Using electronic patient data monitoring systems, the investigators reviewed all patients
      with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity
      or ICUs at the Nantes University Hospital, from January 1, 2012, to december 31, 2015. For
      enrolled patients, general clinical characteristics were collected. Patients were categorized
      into two groups according to the development of an infected pancreatic necrosis (highly
      suspected or proven), and the differences of these characteristics between two groups were
      evaluated. Potential risk factors were collected and studied by using multiple logistic
      regression analysis.
observational model: Case-Control
time perspective: Retrospective
measure: Risk factors of infected pancreatic necrosis
time frame: 4 months
description: Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure
measure: Risk factors of mortality
time frame: 4 months
description: Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (mortality). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of non-survival
arm group label: control patients
description: patients without an infected pancreatic necrosis
arm group label: Case patients
description: patients with an infected pancreatic necrosis
intervention type: Other
intervention name: No intervention
description: No intervention
arm group label: Case patients
arm group label: control patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charlotte Garret, MD
role: Principal Investigator
affiliation: Nantes CHU
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pancreatitis, Acute Necrotizing
mesh term: Necrosis