<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/NCT03284398</url>
  </required_header>
  <id_info>
    <org_study_id>3CBs-001-CNI</org_study_id>
    <nct_id>NCT03284398</nct_id>
  </id_info>
  <brief_title>Three-Chamber Bags Retrospective Study in Spain</brief_title>
  <official_title>Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Kabi</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>
      The primary study objective is to assess the rates of blood stream infection (BSI) from the&#xD;
      use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital&#xD;
      Compounded Bags (HCBs) in patients requiring parenteral nutrition in Spanish hospitals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective observational database study of patients receiving parenteral&#xD;
      nutrition (PN) for at least 3 consecutive days with hospital admission date between January&#xD;
      1, 2013, and December 31, 2015 (study period).&#xD;
&#xD;
      The study will use an as treated approach, where patients will be followed from the index&#xD;
      date (hospital admission day of the hospitalization during which PN is administered) up to&#xD;
      patient discharge or death (observation period).&#xD;
&#xD;
      The study will be conducted using an initial EMR (Electronic Medical Record) data retrieval&#xD;
      process, followed by manual data retrieval (chart review) that will complement data obtained&#xD;
      from EMR. Data collection for manual data retrieval will be conducted through an eCRF.&#xD;
&#xD;
      The documentation of patient data will comprise two sequential steps. The initial step will&#xD;
      include data of 30% of patients and then an interim analysis (IA) will be conducted. If IA&#xD;
      shows positive results, data for the remaining 70% of patients (step II) will be gathered.&#xD;
&#xD;
      The study will be conducted in 10-14 sites in Spain.&#xD;
&#xD;
      Data analysis: Baseline demographics, co-morbidities, and hospitalization characteristics&#xD;
      will be reported descriptively by means of mean with standard deviations and medians with&#xD;
      ranges for continuous variables and by counts and percentages for categorical variables.&#xD;
      Incidence rates for BSI will be reported by treatment group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)</measure>
    <time_frame>Entire study period, from January 1, 2013 and December 31, 2015</time_frame>
    <description>Confirmation of BSI required fulfillment of all of the following criteria:&#xD;
International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32)&#xD;
Positive blood culture collected during PN administration&#xD;
Concomitant antimicrobial therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sepsis During PN</measure>
    <time_frame>From date of admission to date of discharge</time_frame>
    <description>Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment With Antimicrobials During PN</measure>
    <time_frame>Any day during PN treatment</time_frame>
    <description>Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Vasopressor Treatment</measure>
    <time_frame>Patients requiring vasopressor support at any time during treatment with PN</time_frame>
    <description>Percentages of patients requiring vasopressor support during PN treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Mechanical Ventilation</measure>
    <time_frame>Patients requiring mechanical ventilation at any time during PN treatment</time_frame>
    <description>Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Replacement Therapy</measure>
    <time_frame>Patients requiring renal replacement therapy for at least one day during PN treatment</time_frame>
    <description>Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newly-occurred Abnormal Laboratory Findings During PN</measure>
    <time_frame>During PN treatment inclusive day 1</time_frame>
    <description>Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ Failure</measure>
    <time_frame>Any time during PN treatment</time_frame>
    <description>Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay (LOS)</measure>
    <time_frame>Duration in days from admission to death or discharge for each treatment arm</time_frame>
    <description>Hospital length of stay in days for patients for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in the ICU</measure>
    <time_frame>All patients admitted in the ICU at any time during PN treatment</time_frame>
    <description>Total number of days in the ICU for each group (3CB vs HCB)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3723</enrollment>
  <condition>Parenteral Nutrition</condition>
  <condition>Blood Stream Infection</condition>
  <arm_group>
    <arm_group_label>Parenteral nutrition bag type</arm_group_label>
    <description>Groups with different parenteral nutrition bags (3CBs or HCBs)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Population will include adult hospitalized patients receiving PN, treated on any ward and&#xD;
        by any medical discipline within the hospital (e.g., intensive care unit, normal wards;&#xD;
        surgery, non-surgery) during the study period. For every patient, one hospitalization&#xD;
        episode will be documented.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult hospital inpatients ≥ 18 years&#xD;
&#xD;
          2. Treatment with PN for at least 3 consecutive days&#xD;
&#xD;
          3. PN containing all three major macronutrients, delivered from 3CB or HCB&#xD;
&#xD;
          4. Patients with hospital admission between January 1, 2013, and December 31, 2015 (study&#xD;
             period)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Bloodstream infection before or at the same day of first PN administration&#xD;
&#xD;
          2. Immunosuppression due to concomitant therapy (e.g., immunosuppressive therapy due to&#xD;
             transplantation, concomitant oral or intravenous administration of glucocorticoids) or&#xD;
             disease (e.g., HIV, leukaemia)&#xD;
&#xD;
          3. Permanent vascular access (port, shunts for dialysis)&#xD;
&#xD;
          4. Femoral venous placement of central venous line used for PN&#xD;
&#xD;
          5. Burns, extensive skin injuries (e.g., Lyell´s disease)&#xD;
&#xD;
          6. Chemo-/radiotherapy for up to 3 months before hospital admission&#xD;
&#xD;
          7. Change of PN bag type during observation period, e.g., from HCBs to 3CBs or vice-versa&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John F Stover</last_name>
    <role>Study Chair</role>
    <affiliation>Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Juan Carlos M González</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre, 28041 Madrid, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Manacor</name>
      <address>
        <city>Manacor</city>
        <state>Islas Baleares</state>
        <zip>7500</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <results_first_submitted>August 6, 2020</results_first_submitted>
  <results_first_submitted_qc>December 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2021</results_first_posted>
  <last_update_submitted>January 12, 2021</last_update_submitted>
  <last_update_submitted_qc>January 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>parenteral nutrition</keyword>
  <keyword>ICU</keyword>
  <keyword>3-chamber bags</keyword>
  <keyword>ICD-9-CM</keyword>
  <keyword>BSI</keyword>
  <keyword>Medical records system</keyword>
  <keyword>computerized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03284398/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Retrospective cohort study. Data collection from medical records</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Three-chambered Bag (3CB)</title>
          <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period</description>
        </group>
        <group group_id="P2">
          <title>Hospital-Compounded Bag (HCB)</title>
          <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via a Hospital-compounded all-in-one PN bag for ≥3 consecutive days during the study period</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2753"/>
                <participants group_id="P2" count="970"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2753"/>
                <participants group_id="P2" count="970"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 5389 patient records were screened for eligibility; of these, 3723 met the selection criteria, including 2753 patients who received 3CB and 970 patients who received MCB</population>
      <group_list>
        <group group_id="B1">
          <title>Three-Chambered Bag (3CB)</title>
          <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
        </group>
        <group group_id="B2">
          <title>Hospital-compounded Bag (HCB)</title>
          <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2753"/>
            <count group_id="B2" value="970"/>
            <count group_id="B3" value="3723"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2753"/>
                    <count group_id="B2" value="970"/>
                    <count group_id="B3" value="3723"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.8" spread="15.2"/>
                    <measurement group_id="B2" value="66.5" spread="14.8"/>
                    <measurement group_id="B3" value="66.8" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2753"/>
                    <count group_id="B2" value="970"/>
                    <count group_id="B3" value="3723"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1144"/>
                    <measurement group_id="B2" value="354"/>
                    <measurement group_id="B3" value="1498"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1609"/>
                    <measurement group_id="B2" value="616"/>
                    <measurement group_id="B3" value="2225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2753"/>
                    <count group_id="B2" value="970"/>
                    <count group_id="B3" value="3723"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2753"/>
                    <measurement group_id="B2" value="970"/>
                    <measurement group_id="B3" value="3723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)</title>
        <description>Confirmation of BSI required fulfillment of all of the following criteria:&#xD;
International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32)&#xD;
Positive blood culture collected during PN administration&#xD;
Concomitant antimicrobial therapy</description>
        <time_frame>Entire study period, from January 1, 2013 and December 31, 2015</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag</title>
            <description>Treatment with industrially-compounded PN formulation in three-chambered bag</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag</title>
            <description>Treatment with Hospital-compounded PN bag</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)</title>
          <description>Confirmation of BSI required fulfillment of all of the following criteria:&#xD;
International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32)&#xD;
Positive blood culture collected during PN administration&#xD;
Concomitant antimicrobial therapy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sepsis During PN</title>
        <description>Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)</description>
        <time_frame>From date of admission to date of discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period</description>
          </group>
          <group group_id="O2">
            <title>Hospital-Compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Sepsis During PN</title>
          <description>Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="431"/>
                    <measurement group_id="O2" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment With Antimicrobials During PN</title>
        <description>Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)</description>
        <time_frame>Any day during PN treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period</description>
          </group>
          <group group_id="O2">
            <title>Hospital-Compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via a Hospital-compounded all-in-one PN bag for ≥3 consecutive days during the study period</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment With Antimicrobials During PN</title>
          <description>Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="831"/>
                    <measurement group_id="O2" value="370"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Vasopressor Treatment</title>
        <description>Percentages of patients requiring vasopressor support during PN treatment</description>
        <time_frame>Patients requiring vasopressor support at any time during treatment with PN</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Vasopressor Treatment</title>
          <description>Percentages of patients requiring vasopressor support during PN treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410"/>
                    <measurement group_id="O2" value="291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Mechanical Ventilation</title>
        <description>Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)</description>
        <time_frame>Patients requiring mechanical ventilation at any time during PN treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Mechanical Ventilation</title>
          <description>Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410"/>
                    <measurement group_id="O2" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Replacement Therapy</title>
        <description>Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)</description>
        <time_frame>Patients requiring renal replacement therapy for at least one day during PN treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Replacement Therapy</title>
          <description>Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Newly-occurred Abnormal Laboratory Findings During PN</title>
        <description>Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)</description>
        <time_frame>During PN treatment inclusive day 1</time_frame>
        <population>Simultaneous occurring laboratory abnormalities</population>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Newly-occurred Abnormal Laboratory Findings During PN</title>
          <description>Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)</description>
          <population>Simultaneous occurring laboratory abnormalities</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Metabolic impairment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1193"/>
                    <measurement group_id="O2" value="584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any hepatic dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1414"/>
                    <measurement group_id="O2" value="651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any abnormal electrolytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1444"/>
                    <measurement group_id="O2" value="699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Organ Failure</title>
        <description>Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)</description>
        <time_frame>Any time during PN treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Organ Failure</title>
          <description>Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any organ failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="905"/>
                    <measurement group_id="O2" value="562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Single organ failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="593"/>
                    <measurement group_id="O2" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple organ failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="312"/>
                    <measurement group_id="O2" value="307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay (LOS)</title>
        <description>Hospital length of stay in days for patients for each group (3CB vs HCB)</description>
        <time_frame>Duration in days from admission to death or discharge for each treatment arm</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay (LOS)</title>
          <description>Hospital length of stay in days for patients for each group (3CB vs HCB)</description>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26,601"/>
                    <measurement group_id="O2" value="30,384"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in the ICU</title>
        <description>Total number of days in the ICU for each group (3CB vs HCB)</description>
        <time_frame>All patients admitted in the ICU at any time during PN treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Three-Chambered Bag (3CB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
          <group group_id="O2">
            <title>Hospital-compounded Bag (HCB)</title>
            <description>Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015).</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in the ICU</title>
          <description>Total number of days in the ICU for each group (3CB vs HCB)</description>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2753"/>
                <count group_id="O2" value="970"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3,017"/>
                    <measurement group_id="O2" value="3,772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Retrospective, observational, non-interventional study. All-cause mortality, Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed</time_frame>
      <desc>Not applicable since study was retrospective, observational/non-interventional. All-cause mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Three-Chambered Bag (3CB)</title>
          <description>Not applicable (Observational/non-interventional retrospective data collection)</description>
        </group>
        <group group_id="E2">
          <title>Hospital-compounded Bag (HCB)</title>
          <description>Not applicable (Observational/non-interventional retrospective data collection)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prof. Dr. med. Martin Westphal</name_or_title>
      <organization>Fresenius Kabi Deutschland, GmbH</organization>
      <phone>+49 6172 686-7348</phone>
      <email>martin.westphal@fresenius-kabi.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03284398
org study id: 3CBs-001-CNI
nct id: NCT03284398
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary study objective is to assess the rates of blood stream infection (BSI) from the
      use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital
      Compounded Bags (HCBs) in patients requiring parenteral nutrition in Spanish hospitals.
This is a retrospective observational database study of patients receiving parenteral
      nutrition (PN) for at least 3 consecutive days with hospital admission date between January
      1, 2013, and December 31, 2015 (study period).

      The study will use an as treated approach, where patients will be followed from the index
      date (hospital admission day of the hospitalization during which PN is administered) up to
      patient discharge or death (observation period).

      The study will be conducted using an initial EMR (Electronic Medical Record) data retrieval
      process, followed by manual data retrieval (chart review) that will complement data obtained
      from EMR. Data collection for manual data retrieval will be conducted through an eCRF.

      The documentation of patient data will comprise two sequential steps. The initial step will
      include data of 30% of patients and then an interim analysis (IA) will be conducted. If IA
      shows positive results, data for the remaining 70% of patients (step II) will be gathered.

      The study will be conducted in 10-14 sites in Spain.

      Data analysis: Baseline demographics, co-morbidities, and hospitalization characteristics
      will be reported descriptively by means of mean with standard deviations and medians with
      ranges for continuous variables and by counts and percentages for categorical variables.
      Incidence rates for BSI will be reported by treatment group.
observational model: Other
time perspective: Retrospective
measure: Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)
time frame: Entire study period, from January 1, 2013 and December 31, 2015
description: Confirmation of BSI required fulfillment of all of the following criteria:
International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32)
Positive blood culture collected during PN administration
Concomitant antimicrobial therapy
measure: Sepsis During PN
time frame: From date of admission to date of discharge
description: Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)
measure: Treatment With Antimicrobials During PN
time frame: Any day during PN treatment
description: Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)
measure: Use of Vasopressor Treatment
time frame: Patients requiring vasopressor support at any time during treatment with PN
description: Percentages of patients requiring vasopressor support during PN treatment
measure: Use of Mechanical Ventilation
time frame: Patients requiring mechanical ventilation at any time during PN treatment
description: Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)
measure: Renal Replacement Therapy
time frame: Patients requiring renal replacement therapy for at least one day during PN treatment
description: Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)
measure: Newly-occurred Abnormal Laboratory Findings During PN
time frame: During PN treatment inclusive day 1
description: Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)
measure: Organ Failure
time frame: Any time during PN treatment
description: Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)
measure: Hospital Length of Stay (LOS)
time frame: Duration in days from admission to death or discharge for each treatment arm
description: Hospital length of stay in days for patients for each group (3CB vs HCB)
measure: Length of Stay in the ICU
time frame: All patients admitted in the ICU at any time during PN treatment
description: Total number of days in the ICU for each group (3CB vs HCB)
arm group label: Parenteral nutrition bag type
description: Groups with different parenteral nutrition bags (3CBs or HCBs)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John F Stover
role: Study Chair
affiliation: Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
last name: Juan Carlos M González
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: Sepsis
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 