<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/NCT04410315</url>
  </required_header>
  <id_info>
    <org_study_id>Prosp.Laktat.Tumorkraniotomi</org_study_id>
    <nct_id>NCT04410315</nct_id>
  </id_info>
  <brief_title>Hyperlactatemia During and After Tumorcraniotomy</brief_title>
  <official_title>Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
      This study aims to investigate the association between hyperlactatemia and neurological&#xD;
      disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk&#xD;
      factors that induce lactat accumulation will also be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies,&#xD;
      however, are all retrospective, reporting varying effects on clinical outcome. One study&#xD;
      reported new neurological deficitis, some found an association with extended hospital stay,&#xD;
      while others found no association with outcome. It is therefore important to conduct a&#xD;
      prospective study of hyperlactatemia in this patientgroup.&#xD;
&#xD;
      Participants in this study will follow the standard treatment protocol for tumorcraniotomy,&#xD;
      aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of&#xD;
      neurological disability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">February 18, 2022</completion_date>
  <primary_completion_date type="Actual">February 18, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurological disability</measure>
    <time_frame>Change from baseline mRS at 30 days after surgery</time_frame>
    <description>Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>1 year</time_frame>
    <description>In days from admission to discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>After 30 days, 6 months and 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">450</enrollment>
  <condition>Hyperlactatemia</condition>
  <condition>Brain Tumor</condition>
  <condition>Surgery</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Tumorcraniotomy patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum-lactate &lt; 2,2 mmol/L</intervention_name>
    <description>Bloodgas analysis every hour from start surgery until recovery ward discharge</description>
    <arm_group_label>Tumorcraniotomy patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Serum-lactate &gt;/= 2,2 mmol/L</intervention_name>
    <description>Bloodgas analysis every hour from start surgery until recovery ward discharge</description>
    <arm_group_label>Tumorcraniotomy patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing tumorcraniotomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;/= 18 years&#xD;
&#xD;
          -  Must undergo elective tumor craniotomy&#xD;
&#xD;
          -  Understand oral and written Danish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults with incapacity&#xD;
&#xD;
          -  Stereotactic biopsy&#xD;
&#xD;
          -  Lack of informed and signed consent to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neuroanesthesiology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Alexandra Vassilieva</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Hyperlactatemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04410315
org study id: Prosp.Laktat.Tumorkraniotomi
nct id: NCT04410315
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the association between hyperlactatemia and neurological
      disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk
      factors that induce lactat accumulation will also be explored.
Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies,
      however, are all retrospective, reporting varying effects on clinical outcome. One study
      reported new neurological deficitis, some found an association with extended hospital stay,
      while others found no association with outcome. It is therefore important to conduct a
      prospective study of hyperlactatemia in this patientgroup.

      Participants in this study will follow the standard treatment protocol for tumorcraniotomy,
      aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of
      neurological disability.
observational model: Case-Control
time perspective: Prospective
measure: Neurological disability
time frame: Change from baseline mRS at 30 days after surgery
description: Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
measure: Length of hospital stay
time frame: 1 year
description: In days from admission to discharge.
measure: Mortality
time frame: After 30 days, 6 months and 5 years
arm group label: Tumorcraniotomy patients
intervention type: Other
intervention name: Serum-lactate < 2,2 mmol/L
description: Bloodgas analysis every hour from start surgery until recovery ward discharge
arm group label: Tumorcraniotomy patients
intervention type: Other
intervention name: Serum-lactate >/= 2,2 mmol/L
description: Bloodgas analysis every hour from start surgery until recovery ward discharge
arm group label: Tumorcraniotomy patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Alexandra Vassilieva
investigator title: Principal investigator
mesh term: Brain Neoplasms
mesh term: Hyperlactatemia
sharing ipd: Undecided