<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/NCT04403425</url>
  </required_header>
  <id_info>
    <org_study_id>H-19069841</org_study_id>
    <nct_id>NCT04403425</nct_id>
  </id_info>
  <brief_title>Tissue Perfusion During Emergency Laparotomy</brief_title>
  <official_title>Correlation of Central and Peripheral Measures of Tissue Perfusion During Emergency Laparotomy - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</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>
      This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and&#xD;
      stroke volume, after initial fluid resuscitation, in order to assess whether there is a&#xD;
      masked preload responsiveness and ultimately whether the correction of this potential&#xD;
      preload-responsiveness with fluid therapy will translate into increased tissue perfusion in&#xD;
      emergency laparotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Early detection and treatment of insufficient tissue perfusion and oxygenation is the main&#xD;
      purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia,&#xD;
      and low flow states affecting central and peripheral perfusion are frequent in patients&#xD;
      undergoing emergency laparotomy.&#xD;
&#xD;
      This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue&#xD;
      perfusion in patients undergoing emergency laparotomy, to investigate potential&#xD;
      macro/microcirculatory uncoupling.&#xD;
&#xD;
      A single-centre, prospective interventional non-blinded single-arm study at the Department of&#xD;
      Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We&#xD;
      will include patients undergoing emergency laparotomy. The study start is January 2021. After&#xD;
      informed consent, patients will be included if they have an intraoperative need for&#xD;
      Noradrenaline infusion &gt;0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a&#xD;
      goal-directed fluid therapy algorithm. 20 patients will be included.&#xD;
&#xD;
      Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce&#xD;
      NA to investigate whether patients will be preload responsive while maintaining MAP &gt; 50 mmHg&#xD;
      and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge,&#xD;
      we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and&#xD;
      central perfusion indices, including gut perfusion, will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 25, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Preload dependency</measure>
    <time_frame>intraoperatively (during general anesthesia)</time_frame>
    <description>the incidence of preload dependency defined as stroke volume increase of &gt;10% during fluid challenge after reduction of Noradrenaline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue perfusion and fluid status</measure>
    <time_frame>intraoperatively (during general anesthesia)</time_frame>
    <description>changes in perfusion indices (delta values) after NA reduction, one fluid bolus, and subsequent restoration of blood pressure with Noradrenaline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue perfusion</measure>
    <time_frame>intraoperatively (during general anesthesia)</time_frame>
    <description>Other endpoints of interest are the correlation between gut perfusion and indices of central and peripheral perfusion (urethral, cerebral, tissue).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Emergency Laparotomy</condition>
  <condition>Intestinal Obstruction</condition>
  <condition>Perforated Viscus</condition>
  <arm_group>
    <arm_group_label>Emergency laparotomy, obstruction</arm_group_label>
    <description>Patients undergoing emergency laparotomy for intestinal obstruction in need of intraoperative Noradrenaline infusion to maintain predefined normotension.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Emergency laparotomy, perforation</arm_group_label>
    <description>Patients undergoing emergency laparotomy for perforated ventricle or intestine in need of intraoperative Noradrenaline infusion to maintain predefined normotension.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include patients undergoing emergency laparotomy on suspicion of abdominal&#xD;
        pathology, in need of intraoperative Noradrenaline infusion to maintain predefined&#xD;
        normotension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (18 years or over) undergoing emergency laparotomy/laparoscopy for following&#xD;
             abdominal pathology:&#xD;
&#xD;
               1. Perforated viscus&#xD;
&#xD;
               2. Intestinal obstruction&#xD;
&#xD;
          2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus,&#xD;
             anastomotic leakage&#xD;
&#xD;
          3. Provided verbal and written informed consent&#xD;
&#xD;
          4. Must speak and understand the Danish language&#xD;
&#xD;
          5. Intraoperative indication for Norepinephrine infusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies,&#xD;
             herniotomies without bowel resections, sub-acute internal hernias after gastric bypass&#xD;
             surgery, sub-acute surgery for inflammatory bowel diseases.&#xD;
&#xD;
          2. Reoperation owing to fascial separation with no other abdominal pathology identified&#xD;
             and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute&#xD;
             surgery is defined as surgery planned within 48 hours.&#xD;
&#xD;
          3. Intestinal Ischemia&#xD;
&#xD;
          4. intraabdominal bleeding&#xD;
&#xD;
          5. Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.&#xD;
&#xD;
          6. Dementia and/or cognitive dysfunction (diagnosed). If the patient is not awake, alert,&#xD;
             and oriented, times three (to person, place, and time), this also qualifies as an&#xD;
             exclusion criterion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Copenhagen University Hospital Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mirjana Cihoric, MD</last_name>
      <phone>+4522475828</phone>
      <email>mirjana.cihoric.03@regionh.dk</email>
    </contact>
    <contact_backup>
      <last_name>Nicolai Bang Foss, MD, DMSc</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 27, 2022</last_update_submitted>
  <last_update_submitted_qc>March 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Mirjana Cihoric</investigator_full_name>
    <investigator_title>MD, Research fellow</investigator_title>
  </responsible_party>
  <keyword>emergency laparotomy</keyword>
  <keyword>tissue perfusion</keyword>
  <keyword>hemodynamic instability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Obstruction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04403425
org study id: H-19069841
nct id: NCT04403425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is investigating the effect of intraoperative Noradrenaline on cardiac preload and
      stroke volume, after initial fluid resuscitation, in order to assess whether there is a
      masked preload responsiveness and ultimately whether the correction of this potential
      preload-responsiveness with fluid therapy will translate into increased tissue perfusion in
      emergency laparotomy.
Early detection and treatment of insufficient tissue perfusion and oxygenation is the main
      purpose of perioperative haemodynamic monitoring and management. Hypovolemia, septicaemia,
      and low flow states affecting central and peripheral perfusion are frequent in patients
      undergoing emergency laparotomy.

      This study aims to assess the effects of Noradrenaline (NA) on cardiac preload, and tissue
      perfusion in patients undergoing emergency laparotomy, to investigate potential
      macro/microcirculatory uncoupling.

      A single-centre, prospective interventional non-blinded single-arm study at the Department of
      Anaesthesiology and Intensive care Unit, Copenhagen University Hospital Hvidovre, Denmark. We
      will include patients undergoing emergency laparotomy. The study start is January 2021. After
      informed consent, patients will be included if they have an intraoperative need for
      Noradrenaline infusion >0.1 mcg/kg/min to maintain MAP ≥65 mmHg after resuscitation with a
      goal-directed fluid therapy algorithm. 20 patients will be included.

      Intervention: At a steady state (MAP ≥65 mmHg) during the surgical procedure, we will reduce
      NA to investigate whether patients will be preload responsive while maintaining MAP > 50 mmHg
      and limiting stroke volume reduction to no more than 30%. After a subsequent fluid challenge,
      we will increase the dose of NA to re-establish a MAP ≥65 mmHg. In addition, peripheral and
      central perfusion indices, including gut perfusion, will be measured.
observational model: Cohort
time perspective: Prospective
measure: Preload dependency
time frame: intraoperatively (during general anesthesia)
description: the incidence of preload dependency defined as stroke volume increase of >10% during fluid challenge after reduction of Noradrenaline.
measure: Tissue perfusion and fluid status
time frame: intraoperatively (during general anesthesia)
description: changes in perfusion indices (delta values) after NA reduction, one fluid bolus, and subsequent restoration of blood pressure with Noradrenaline.
measure: Tissue perfusion
time frame: intraoperatively (during general anesthesia)
description: Other endpoints of interest are the correlation between gut perfusion and indices of central and peripheral perfusion (urethral, cerebral, tissue).
arm group label: Emergency laparotomy, obstruction
description: Patients undergoing emergency laparotomy for intestinal obstruction in need of intraoperative Noradrenaline infusion to maintain predefined normotension.
arm group label: Emergency laparotomy, perforation
description: Patients undergoing emergency laparotomy for perforated ventricle or intestine in need of intraoperative Noradrenaline infusion to maintain predefined normotension.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Mirjana Cihoric
investigator title: MD, Research fellow
mesh term: Intestinal Obstruction
mesh term: Emergencies
sharing ipd: No