xml: <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/NCT05992961</url>
    </required_header>
    <id_info>
      <org_study_id>P-2020-507-2</org_study_id>
      <nct_id>NCT05992961</nct_id>
    </id_info>
    <brief_title>The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery</brief_title>
    <official_title>The Effects of Troponin I Surveillance Among Patients Undergoing Acute High-risk Abdominal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nordsjaellands Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nordsjaellands 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>
        Treatment of disorders such as gastrointestinal tract (GI) perforation, ischemia and&#xD;
        obstruction often require acute high-risk abdominal surgery, which is associated with a high&#xD;
        risk of complications such as myocardial injury after non-cardiac surgery (MINS) and&#xD;
        mortality. The majority of patients with MINS will not experience any symptoms, and thus MINS&#xD;
        remains undetected without routine troponin measurements.&#xD;
  &#xD;
        The investigators hypothesized that implementing surveillance with troponin I as a standard&#xD;
        care might be useful as risk stratification, and that increased surveillance, examinations,&#xD;
        and subsequent individually based medical interventions, might improve the outcomes for&#xD;
        patients with MINS.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2018</start_date>
    <completion_date type="Actual">February 28, 2021</completion_date>
    <primary_completion_date type="Actual">February 28, 2021</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>compare the mortality rate before and after implementing troponin I surveillance</measure>
      <time_frame>30-, 90-, and 365-day</time_frame>
      <description>compare the 30-, 90-, and 365-day mortality rate after acute hugh-risk abdominal surgery in patients undergoing postoperative troponin I surveillance and subsequent intervention with a historical group of patients not undergoing troponin I surveillance.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">558</enrollment>
    <condition>Abdomen, Acute</condition>
    <condition>Myocardial Injury After Non-cardiac Surgery</condition>
    <condition>Troponin I</condition>
    <condition>Myocardial Injury</condition>
    <condition>Emergency Surgery</condition>
    <arm_group>
      <arm_group_label>Patients not undergoing troponin I surveillance</arm_group_label>
      <description>Patients undergoing acute high-risk abdominal surgery during the period February 1, 2018, to February 28, 2019. No troponin I measurements were made.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients undergoing troponin I surveillance</arm_group_label>
      <description>Patients undergoing acute high-risk abdominal surgery during the period March 1, 2019, to February 28, 2021 as well as postoperative troponin I surveillance .</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Troponin I</intervention_name>
      <description>Troponin I were measured 6-12 hours postoperatively and on each of the succeeding four postoperative days for patients operated March 1, 2019, to February 28, 2021.&#xD;
  Patients with increased troponin I levels were assessed regarding symptoms of myocardial ischaemia including electrocardiography. Each patient was individually assessed, and relevant treatment and follow-up were planned in collaboration between surgeons, cardiologists, and anaesthesiologists.</description>
      <arm_group_label>Patients undergoing troponin I surveillance</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing acute high-risk abdominal surgery at Copenhagen University Hospital -&#xD;
          North Zealand, Denmark during the period February 1, 2018, to February 28, 2021.&#xD;
  &#xD;
          For patients undergoing acute high-risk abdominal surgery on more than occasion during the&#xD;
          period of observation, only the first case of surgery was included.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible patients were 18 years or older&#xD;
  &#xD;
            -  Undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia&#xD;
               or necrosis, or anastomotic leakage.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not undergoing surgery for one of the conditions above&#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>Claus Anders TB Bertelsen, PhD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Copenhagen University Hospital - North Zealand</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Copenhagen University Hospital - North Zealand</name>
        <address>
          <city>Hillerød</city>
          <zip>3400</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Abdomen, Acute</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD can be shared at request.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992961
  org study id: P-2020-507-2
  nct id: NCT05992961
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Treatment of disorders such as gastrointestinal tract (GI) perforation, ischemia and
        obstruction often require acute high-risk abdominal surgery, which is associated with a high
        risk of complications such as myocardial injury after non-cardiac surgery (MINS) and
        mortality. The majority of patients with MINS will not experience any symptoms, and thus MINS
        remains undetected without routine troponin measurements.
  
        The investigators hypothesized that implementing surveillance with troponin I as a standard
        care might be useful as risk stratification, and that increased surveillance, examinations,
        and subsequent individually based medical interventions, might improve the outcomes for
        patients with MINS.
  observational model: Cohort
  time perspective: Retrospective
  measure: compare the mortality rate before and after implementing troponin I surveillance
  time frame: 30-, 90-, and 365-day
  description: compare the 30-, 90-, and 365-day mortality rate after acute hugh-risk abdominal surgery in patients undergoing postoperative troponin I surveillance and subsequent intervention with a historical group of patients not undergoing troponin I surveillance.
  arm group label: Patients not undergoing troponin I surveillance
  description: Patients undergoing acute high-risk abdominal surgery during the period February 1, 2018, to February 28, 2019. No troponin I measurements were made.
  arm group label: Patients undergoing troponin I surveillance
  description: Patients undergoing acute high-risk abdominal surgery during the period March 1, 2019, to February 28, 2021 as well as postoperative troponin I surveillance .
  intervention type: Diagnostic Test
  intervention name: Troponin I
  description: Troponin I were measured 6-12 hours postoperatively and on each of the succeeding four postoperative days for patients operated March 1, 2019, to February 28, 2021.
  Patients with increased troponin I levels were assessed regarding symptoms of myocardial ischaemia including electrocardiography. Each patient was individually assessed, and relevant treatment and follow-up were planned in collaboration between surgeons, cardiologists, and anaesthesiologists.
  arm group label: Patients undergoing troponin I surveillance
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Claus Anders TB Bertelsen, PhD, MD
  role: Principal Investigator
  affiliation: Copenhagen University Hospital - North Zealand
  facility: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Emergencies
  mesh term: Abdomen, Acute
  mesh term: Wounds and Injuries
  sharing ipd: No
  ipd description: IPD can be shared at request.