<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/NCT03010969</url>
  </required_header>
  <id_info>
    <org_study_id>POETRY abdominal</org_study_id>
    <nct_id>NCT03010969</nct_id>
  </id_info>
  <brief_title>Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery</brief_title>
  <acronym>POETRYabd</acronym>
  <official_title>Perioperative Endothelial Dysfunction in Patients Undergoing Major Acute Abdominal Surgery. The POETRY Abdominal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the clinical study is:&#xD;
&#xD;
        1. to examine the association between postoperative endothelial function, indirectly&#xD;
           measured by reactive hyperemia index, and major adverse cardiovascular events including&#xD;
           myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal&#xD;
           surgery.&#xD;
&#xD;
        2. to examine the association between postoperative endothelial function, indirectly&#xD;
           measured by reactive hyperemia index, and non-cardiovascular complications including&#xD;
           non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.&#xD;
&#xD;
        3. to examine the importance of the postoperative blood glucose level and the pulmonary&#xD;
           function for postoperative complications and death within 30, 90 and 365 days of acute&#xD;
           abdominal surgery.&#xD;
&#xD;
        4. to examine the association between postoperative endothelial function, pulmonary&#xD;
           function and blood glucose level&#xD;
&#xD;
        5. the qualitative part of the study will examine the postoperative subjective symptoms&#xD;
           including acute and chronic pain, quality of recovery and functional status, depressive&#xD;
           thoughts and post-traumatic stress disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 2018</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>The change in reactive hyperemia index assessed by EndoPat</measure>
    <time_frame>The change from 4-24 hours to between day 3 and 5 after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major adverse cardiovascular events</measure>
    <time_frame>Within 365 days of surgery</time_frame>
    <description>Cardiovascular death&#xD;
Myocardial injury within postoperative day 3 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L))&#xD;
Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI)&#xD;
Congestive heart failure&#xD;
Stroke&#xD;
Nonfatal cardiac arrest&#xD;
New clinically important cardiac arrhythmia&#xD;
Coronary revascularization procedure (PCI or CABG)&#xD;
Sudden unexpected death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative non-cardiovascular complications</measure>
    <time_frame>Within 365 days of surgery</time_frame>
    <description>Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nitric oxide biomarkers</measure>
    <time_frame>4-24 hours after surgery and between postoperative day 3-5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive hyperemia index assessed by EndoPat</measure>
    <time_frame>4-24 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactive hyperemia index assessed by EndoPat</measure>
    <time_frame>between day 3 and 5 after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose level</measure>
    <time_frame>Postoperative day 1 - 7 (or until discharge)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>Postoperative day 1 - 7 (or until discharge)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>Readmissions within 1 year of discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lengths of stay</measure>
    <time_frame>Lengths of stay from the operation day to discharge, on average 14 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lengths of stay in the intensive care unit</measure>
    <time_frame>Lengths of stay from the operation day to discharge from hospital, on average 14 days.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Postoperative quality of recovery (QoR15)</measure>
    <time_frame>postoperative day 1, 3, 5, 7, 14, 30, 90 and 365</time_frame>
    <description>QoR15 score</description>
  </other_outcome>
  <other_outcome>
    <measure>Numerical rating scale (NRS) pain score</measure>
    <time_frame>postoperative day 1, 3, 5, 7, 14, 30, 90 and 365</time_frame>
    <description>NRS pain score in rest and at activity</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-Traumatic Stress Disorder</measure>
    <time_frame>postoperative day 14, 30, 90 and 365</time_frame>
    <description>Post-Traumatic Stress Disorder questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive thoughts</measure>
    <time_frame>postoperative day 14, 30, 90 and 365</time_frame>
    <description>Hospital anxiety and depression scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>postoperative day 14, 30, 90 and 365</time_frame>
    <description>Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional status</measure>
    <time_frame>postoperative day 14, 30, 90 and 365</time_frame>
    <description>Activity Assessment Scale</description>
  </other_outcome>
  <enrollment type="Actual">224</enrollment>
  <condition>Cardiovascular Complication</condition>
  <condition>Complication, Postoperative</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acute abdominal surgery</intervention_name>
    <description>Acute abdominal surgery within 72 hours of admission to the department of surgery</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The blood will be collected from a larger vein (e.g. the cubital vein). Cardiac troponin I&#xD;
      Tetrahydrobiopterin: Blood is sampled into 4mL EDTA tubes. Immediately after withdrawal, a&#xD;
      minimum of 1mL blood is mixed with 25μL DTE. The mixture is centrifuged at 2000g for 5&#xD;
      minutes. Plasma is frozen and stored at -80°C.&#xD;
&#xD;
      Arginine and ADMA: Blood is sampled into 4mL EDTA tubes. Blood samples will be centrifuged at&#xD;
      3000g for 10 minutes, plasma frozen and stored at -80°C until analyzed with high performance&#xD;
      liquid chromatography.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing major acute gastrointestinal surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Surgery within 72 hours of an acute admission to the Department of Surgery or an acute&#xD;
             reoperation.&#xD;
&#xD;
          -  Major gastrointestinal surgery on the gastrointestinal tract. This will include&#xD;
&#xD;
          -  Open, laparoscopic, or laparoscopically-assisted procedures&#xD;
&#xD;
          -  Procedures involving the stomach, small or large bowel, or rectum for conditions such&#xD;
             as perforation, ischaemia, abdominal abscess, bleeding or obstruction&#xD;
&#xD;
          -  Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or&#xD;
             cholecystitis - excluded, see below)&#xD;
&#xD;
          -  Washout/evacuation of intra-peritoneal hematoma&#xD;
&#xD;
          -  Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias&#xD;
             (but not hernia repair without bowel resection/repair)&#xD;
&#xD;
          -  Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the&#xD;
             presentation and findings were acute&#xD;
&#xD;
          -  Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)&#xD;
&#xD;
          -  Laparoscopic/Open Adhesiolysis&#xD;
&#xD;
          -  Return to theatre for repair of fascial dehiscence&#xD;
&#xD;
          -  Any reoperation/return to theatre meeting the criteria above is included&#xD;
&#xD;
        If multiple procedures (primary surgery or reoperation) are performed on different&#xD;
        anatomical sites within the abdominal/pelvic cavity, the patient would be included if the&#xD;
        major procedure is general surgical.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Not capable of giving informed consent after oral and written information&#xD;
&#xD;
          -  Previously included in the trial&#xD;
&#xD;
          -  If transferred directly from the operation room or recovery ward to the intensive care&#xD;
             unit&#xD;
&#xD;
          -  Elective laparoscopy&#xD;
&#xD;
          -  Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if&#xD;
             no procedure is performed because of inoperable pathology, then include)&#xD;
&#xD;
          -  Appendectomy +/- drainage of localized collection unless the procedure is incidental&#xD;
             to a non-elective procedure on the GI tract&#xD;
&#xD;
          -  Cholecystectomy +/- drainage of localized collection unless the procedure is&#xD;
             incidental to a non-elective procedure on the GI tract (All surgery involving the&#xD;
             appendix or gallbladder, including any surgery relating to complications such as&#xD;
             abscess or bile leak is excluded)&#xD;
&#xD;
          -  Non-elective hernia repair without bowel resection.&#xD;
&#xD;
          -  Minor abdominal wound dehiscence unless this causes bowel complications requiring&#xD;
             resection&#xD;
&#xD;
          -  Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease&#xD;
&#xD;
          -  Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma&#xD;
&#xD;
          -  Laparotomy/laparoscopy for esophageal pathology Laparotomy/laparoscopy for pathology&#xD;
             of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or&#xD;
             urinary tract&#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>Sarah Ekeloef, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, Zealand University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jakob Burcharth, MD, Phd.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, Zealand University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, Zealand University Hospital, Koge</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 14, 2021</last_update_submitted>
  <last_update_submitted_qc>February 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Sarah Victoria Ekeløf Busch</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Endothelial dysfunction</keyword>
  <keyword>Surgery</keyword>
  <keyword>Pulmonary function</keyword>
  <keyword>Blood glucose level</keyword>
  <keyword>Patient-related outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to share IPD</ipd_description>
  </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/NCT03010969
org study id: POETRY abdominal
nct id: NCT03010969
lead sponsor: 
has dmc: No
The aim of the clinical study is:

        1. to examine the association between postoperative endothelial function, indirectly
           measured by reactive hyperemia index, and major adverse cardiovascular events including
           myocardial injury and cardiac death within 30, 90 and 365 days of acute abdominal
           surgery.

        2. to examine the association between postoperative endothelial function, indirectly
           measured by reactive hyperemia index, and non-cardiovascular complications including
           non-cardiac death within 30, 90 and 365 days of acute abdominal surgery.

        3. to examine the importance of the postoperative blood glucose level and the pulmonary
           function for postoperative complications and death within 30, 90 and 365 days of acute
           abdominal surgery.

        4. to examine the association between postoperative endothelial function, pulmonary
           function and blood glucose level

        5. the qualitative part of the study will examine the postoperative subjective symptoms
           including acute and chronic pain, quality of recovery and functional status, depressive
           thoughts and post-traumatic stress disorder.
observational model: Cohort
time perspective: Prospective
measure: The change in reactive hyperemia index assessed by EndoPat
time frame: The change from 4-24 hours to between day 3 and 5 after surgery
measure: Major adverse cardiovascular events
time frame: Within 365 days of surgery
description: Cardiovascular death
Myocardial injury within postoperative day 3 (definition: peak plasma cardiac troponin-I ≥ 45ng/L (99th percentile URL, 10% CV at 40ng/L))
Acute coronary syndrome (unstable angina pectoris, NSTEMI, STEMI)
Congestive heart failure
Stroke
Nonfatal cardiac arrest
New clinically important cardiac arrhythmia
Coronary revascularization procedure (PCI or CABG)
Sudden unexpected death
measure: Postoperative non-cardiovascular complications
time frame: Within 365 days of surgery
description: Non-cardiovascular death, sepsis, pneumonia, respiratory failure, surgical complications (min. Clavien-Dindo stage 3), Any non-cardiovascular life-threatening complication (Clavien-Dindo stage 4).
measure: Nitric oxide biomarkers
time frame: 4-24 hours after surgery and between postoperative day 3-5
measure: Reactive hyperemia index assessed by EndoPat
time frame: 4-24 hours after surgery
measure: Reactive hyperemia index assessed by EndoPat
time frame: between day 3 and 5 after surgery
measure: Blood Glucose level
time frame: Postoperative day 1 - 7 (or until discharge)
measure: Pulmonary function
time frame: Postoperative day 1 - 7 (or until discharge)
measure: Readmission
time frame: Readmissions within 1 year of discharge
measure: Lengths of stay
time frame: Lengths of stay from the operation day to discharge, on average 14 days.
measure: Lengths of stay in the intensive care unit
time frame: Lengths of stay from the operation day to discharge from hospital, on average 14 days.
measure: Postoperative quality of recovery (QoR15)
time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
description: QoR15 score
measure: Numerical rating scale (NRS) pain score
time frame: postoperative day 1, 3, 5, 7, 14, 30, 90 and 365
description: NRS pain score in rest and at activity
measure: Post-Traumatic Stress Disorder
time frame: postoperative day 14, 30, 90 and 365
description: Post-Traumatic Stress Disorder questionnaire
measure: Depressive thoughts
time frame: postoperative day 14, 30, 90 and 365
description: Hospital anxiety and depression scale
measure: Postoperative pain
time frame: postoperative day 14, 30, 90 and 365
description: Questionnaire Self-reported Leeds Assessment of Neuropatic Symptoms and Signs pain scale (S-LANSS)
measure: Functional status
time frame: postoperative day 14, 30, 90 and 365
description: Activity Assessment Scale
intervention type: Procedure
intervention name: Acute abdominal surgery
description: Acute abdominal surgery within 72 hours of admission to the department of surgery
The blood will be collected from a larger vein (e.g. the cubital vein). Cardiac troponin I
      Tetrahydrobiopterin: Blood is sampled into 4mL EDTA tubes. Immediately after withdrawal, a
      minimum of 1mL blood is mixed with 25μL DTE. The mixture is centrifuged at 2000g for 5
      minutes. Plasma is frozen and stored at -80°C.

      Arginine and ADMA: Blood is sampled into 4mL EDTA tubes. Blood samples will be centrifuged at
      3000g for 10 minutes, plasma frozen and stored at -80°C until analyzed with high performance
      liquid chromatography.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah Ekeloef, MD
role: Principal Investigator
affiliation: Department of Surgery, Zealand University Hospital
last name: Jakob Burcharth, MD, Phd.
role: Principal Investigator
affiliation: Department of Surgery, Zealand University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Sarah Victoria Ekeløf Busch
investigator title: MD
mesh term: Postoperative Complications
sharing ipd: No
ipd description: We do not plan to share IPD