<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/NCT03015233</url>
  </required_header>
  <id_info>
    <org_study_id>AFERSAU-2016-01</org_study_id>
    <nct_id>NCT03015233</nct_id>
  </id_info>
  <brief_title>Acute Abdominal Pain: Evaluation of Lactate Value as Predictive Factor of Surgical Issue</brief_title>
  <acronym>GALAC</acronym>
  <official_title>Acute Abdominal Pain in Emergency Department: Evaluation of Venous LACtate Value and Strong Ion GAp According to the Stewart Approach as Predictive Factors of Surgical Issue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences</source>
  <brief_summary>
    <textblock>
      Abdominal pain is one of the most common reasons for consultation in Emergency Departments&#xD;
      (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The&#xD;
      actual gold standard for diagnosis is computed tomography (CT). However with this procedure&#xD;
      there is high radiation exposure and a risk factor of radiation-induced cancers, therefore&#xD;
      alternative diagnostic techniques should be considered. The aim of this study is to evaluate&#xD;
      the performance of measuring venous lactate in patients presenting with acute abdominal pain&#xD;
      in ED.&#xD;
&#xD;
      In this single-center, prospective, non-interventional study, the diagnostic accuracy of&#xD;
      venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here&#xD;
      is that venous lactatemia is a positive predictive factor of surgical emergencies in patients&#xD;
      with acute abdominal pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abdominal pain is one of the most common reasons for consultation worldwide in Emergency&#xD;
      Departments (ED). The challenge for physicians is to not misdiagnose a surgical emergency.&#xD;
      The actual gold standard for diagnosis is computed tomography (CT). However with this&#xD;
      procedure there is high radiation exposure and a risk factor of radiation-induced cancers,&#xD;
      therefore alternative diagnostic techniques should be considered. The aim of this study is to&#xD;
      evaluate the diagnostic performance of measuring venous lactate in patients with acute&#xD;
      abdominal pain in ED.&#xD;
&#xD;
      A single-center, prospective, non-interventional study, will be conducted between June 2016&#xD;
      and January 2017 in the university emergency department of Nice, France. Inclusion criteria&#xD;
      are patients aged 18 and over, suffering from abdominal pain for seven days or less and&#xD;
      requiring a blood test to help with diagnosis.&#xD;
&#xD;
      The primary outcome is to determine if the value of venous lactate is a predictive factor of&#xD;
      emergency surgery in patients with acute abdominal pain.&#xD;
&#xD;
      The secondary outcome is to determine if the &quot;strong ion gap&quot;, first defined in &quot;The Stewart&#xD;
      Approach&quot;, is a predictive factor of emergency surgery in patients with acute abdominal pain.&#xD;
&#xD;
      A blood test will be performed when patients are admitted to the ED. Seven days after being&#xD;
      admitted to the ED, patients' outcome will be assessed by consulting patients' medical&#xD;
      records or by phone call.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <primary_completion_date type="Anticipated">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Venous lactate value</measure>
    <time_frame>At admission of patient in the ED (Day 1) between arrival and up to one hour later</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical issue</measure>
    <time_frame>From Day 1 (D1) to Day 7 (D7)</time_frame>
    <description>The occurence/or not of a surgical outcome in patients with acute abdomen, during the seven days following the ED visit, will be assessed by consulting patients' medical records or by calling them at D7.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Strong ion gap as Stewart approach</measure>
    <time_frame>At admission of patient in the ED (Day 1) between arrival and up to one hour later</time_frame>
    <description>Strong ion gap (SIG) is a calculated value based on the following equation :&#xD;
SIG = (Na+ + K+ + 2xCa2+ + 2xMg2+) - (Cl- - lactate) - HCO3- + albumine x (0.123 x PH - 0.631) + phosphates mesurés x (0.309 x PH - 0.469) All the values are measured on venous samples.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">660</enrollment>
  <condition>Abdomen, Acute</condition>
  <condition>Renal Colic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting abdominal pain since seven days or less, older than 18 years old, and&#xD;
        who need a blood analysis to perform diagnosis after physician's clinical evaluation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  Patient presenting acute abdominal pain since 7 days or less&#xD;
&#xD;
          -  Need of blood sample confirmed by physician&#xD;
&#xD;
          -  Affiliation to french social security system&#xD;
&#xD;
          -  Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post traumatic abdominal pain / occurrence of abdominal trauma in the 7 days before ED&#xD;
             visit&#xD;
&#xD;
          -  Patients with cirrhosis classified as Child-Pugh C&#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>Julie CONTENTI, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pauline S SIVRY, MD</last_name>
    <phone>+33492038687</phone>
    <phone_ext>+33</phone_ext>
    <email>sivry.p@chu-nice.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jocelyn F RAPP, MS</last_name>
    <phone>+33492038535</phone>
    <phone_ext>+33</phone_ext>
    <email>rapp.j@chu-nice.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nice University Hospital - Pasteur 2</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pauline S SIVRY, MD</last_name>
      <phone>+33492038687</phone>
      <phone_ext>+33</phone_ext>
      <email>sivry.p@chu-nice.fr</email>
    </contact>
    <contact_backup>
      <last_name>Jocelyn F RAPP, MS</last_name>
      <phone>+33492038535</phone>
      <phone_ext>+33</phone_ext>
      <email>rapp.j@chu-nice.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Pauline S SIVRY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julie CONTENTI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 6, 2017</last_update_submitted>
  <last_update_submitted_qc>January 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lactate</keyword>
  <keyword>Acute Abdominal Pain</keyword>
  <keyword>Acute Abdomen</keyword>
  <keyword>Strong Ion Gap</keyword>
  <keyword>Renal Colic</keyword>
  <keyword>Emergency Department</keyword>
  <keyword>Emergency</keyword>
  <keyword>Surgery</keyword>
  <keyword>Stewart</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
    <mesh_term>Renal Colic</mesh_term>
    <mesh_term>Abdomen, Acute</mesh_term>
  </condition_browse>
  <!-- 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/NCT03015233
org study id: AFERSAU-2016-01
nct id: NCT03015233
lead sponsor: 
Abdominal pain is one of the most common reasons for consultation in Emergency Departments
      (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The
      actual gold standard for diagnosis is computed tomography (CT). However with this procedure
      there is high radiation exposure and a risk factor of radiation-induced cancers, therefore
      alternative diagnostic techniques should be considered. The aim of this study is to evaluate
      the performance of measuring venous lactate in patients presenting with acute abdominal pain
      in ED.

      In this single-center, prospective, non-interventional study, the diagnostic accuracy of
      venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here
      is that venous lactatemia is a positive predictive factor of surgical emergencies in patients
      with acute abdominal pain.
Abdominal pain is one of the most common reasons for consultation worldwide in Emergency
      Departments (ED). The challenge for physicians is to not misdiagnose a surgical emergency.
      The actual gold standard for diagnosis is computed tomography (CT). However with this
      procedure there is high radiation exposure and a risk factor of radiation-induced cancers,
      therefore alternative diagnostic techniques should be considered. The aim of this study is to
      evaluate the diagnostic performance of measuring venous lactate in patients with acute
      abdominal pain in ED.

      A single-center, prospective, non-interventional study, will be conducted between June 2016
      and January 2017 in the university emergency department of Nice, France. Inclusion criteria
      are patients aged 18 and over, suffering from abdominal pain for seven days or less and
      requiring a blood test to help with diagnosis.

      The primary outcome is to determine if the value of venous lactate is a predictive factor of
      emergency surgery in patients with acute abdominal pain.

      The secondary outcome is to determine if the "strong ion gap", first defined in "The Stewart
      Approach", is a predictive factor of emergency surgery in patients with acute abdominal pain.

      A blood test will be performed when patients are admitted to the ED. Seven days after being
      admitted to the ED, patients' outcome will be assessed by consulting patients' medical
      records or by phone call.
observational model: Case-Only
time perspective: Prospective
measure: Venous lactate value
time frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later
measure: Surgical issue
time frame: From Day 1 (D1) to Day 7 (D7)
description: The occurence/or not of a surgical outcome in patients with acute abdomen, during the seven days following the ED visit, will be assessed by consulting patients' medical records or by calling them at D7.
measure: Strong ion gap as Stewart approach
time frame: At admission of patient in the ED (Day 1) between arrival and up to one hour later
description: Strong ion gap (SIG) is a calculated value based on the following equation :
SIG = (Na+ + K+ + 2xCa2+ + 2xMg2+) - (Cl- - lactate) - HCO3- + albumine x (0.123 x PH - 0.631) + phosphates mesurés x (0.309 x PH - 0.469) All the values are measured on venous samples.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie CONTENTI, MD
role: Study Chair
affiliation: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences
last name: Pauline S SIVRY, MD
phone: +33492038687
phone ext: +33
email: sivry.p@chu-nice.fr
last name: Jocelyn F RAPP, MS
phone: +33492038535
phone ext: +33
email: rapp.j@chu-nice.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Abdominal Pain
mesh term: Renal Colic
mesh term: Abdomen, Acute