<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/NCT01692639</url>
  </required_header>
  <id_info>
    <org_study_id>5313</org_study_id>
    <nct_id>NCT01692639</nct_id>
  </id_info>
  <brief_title>Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?</brief_title>
  <official_title>Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acetaminophen is the first drug involved in voluntary drug poisoning. According to the&#xD;
      studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver&#xD;
      failure, and this poisoning is responsible of 10 percent of liver transplants each year in&#xD;
      these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk&#xD;
      factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly&#xD;
      correlated with factors predisposing socio-economic field are an important issue, including&#xD;
      the speed and appropriateness of care are key factors both in terms of reducing morbidity&#xD;
      mortality in socio-economic terms for the community.A nomogram defines a statistical&#xD;
      threshold from which the blood concentration of paracetamol has a significant risk of liver&#xD;
      toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a&#xD;
      toxic dose, but there is no consensus on whether or not to repeat this dosage during the&#xD;
      treatment, as the first result is beyond the threshold or not.The administration of the&#xD;
      antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a&#xD;
      protocol that can vary in different services.In the absence of clear guidelines, the question&#xD;
      of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion&#xD;
      if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it&#xD;
      possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the&#xD;
      curve, and thus enable the return home of the patient's somatic point of view (excluding&#xD;
      psychiatric care when is voluntary drug intoxication), with consequences in terms of costs&#xD;
      (hospital days) and duration of treatment?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>
  <enrollment type="Actual">4</enrollment>
  <condition>Acetaminophen Overdose</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients over 18 years with acute paracetamol ingestion admitted in a group of 8 emergency&#xD;
        departments of the region Alsace, France (Strasbourg Hautepierre and Nouvel Hôpital Civil,&#xD;
        Haguenau, Saverne,Wissembourg, Colmar, Sélestat, Mulhouse) and with a single dose of&#xD;
        paracetamol over 4 grams.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years&#xD;
&#xD;
          -  Having taken a single dose of acetaminophen&#xD;
&#xD;
          -  With a supposed ingested dose over 4 grams&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated with N-Acetyl&#xD;
&#xD;
          -  Cysteine before their admissions in the participating units&#xD;
&#xD;
          -  With repeted ingested doses&#xD;
&#xD;
          -  Pregnant and nursing wifes&#xD;
&#xD;
          -  Patients unable to give their consent to the 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>
  <overall_official>
    <last_name>Pascal BILBAULT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux Universitaires de Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Gérontologique</name>
      <address>
        <city>Bischwiller</city>
        <zip>67241</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'accueil des Urgences, Hôpitaux Civils de Colmar, Centre Hospitalier Louis Pasteur</name>
      <address>
        <city>Colmar</city>
        <zip>68024</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Accueil des Urgences, Centre Hospitalier de Haguenau</name>
      <address>
        <city>Haguenau</city>
        <zip>67500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service des Urgences, CH Emile Muller</name>
      <address>
        <city>Mulhouse</city>
        <zip>68051</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service des Urgences, Centre Hospitalier de Sélestat</name>
      <address>
        <city>Selestat</city>
        <zip>67606</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'Accueil des Urgences, Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Réanimation Médicale, Nouvel Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Réanimation Médicale, Hôpital de Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service des Urgences, Hôpital de Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service des Urgences, Centre Hospitalier Intercommunal de la Lauter</name>
      <address>
        <city>Wissembourg</city>
        <zip>67160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2016</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>Drug Overdose</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/NCT01692639
org study id: 5313
nct id: NCT01692639
lead sponsor: 
has dmc: No
Acetaminophen is the first drug involved in voluntary drug poisoning. According to the
      studies conducted in the USA and in the United Kingdom, it is the first cause of acute liver
      failure, and this poisoning is responsible of 10 percent of liver transplants each year in
      these countries. Mortality is about 1/3 at the stage of acute liver failure. The main risk
      factors are malnutrition and chronic alcoholism. Ease of access to this toxic and highly
      correlated with factors predisposing socio-economic field are an important issue, including
      the speed and appropriateness of care are key factors both in terms of reducing morbidity
      mortality in socio-economic terms for the community.A nomogram defines a statistical
      threshold from which the blood concentration of paracetamol has a significant risk of liver
      toxicity. The blood paracetamol dosage practiced today at the 4th hour after ingestion of a
      toxic dose, but there is no consensus on whether or not to repeat this dosage during the
      treatment, as the first result is beyond the threshold or not.The administration of the
      antidote NAC (N-acetyl-cysteine) in proven cases of liver toxicity is also regulated by a
      protocol that can vary in different services.In the absence of clear guidelines, the question
      of the need for iterative dosages of paracetamol blood beyond the fourth hour post-ingestion
      if the initial paracetamol blood measurement is below the curve nomogram remains open.Is it
      possible to limit blood tests to a single assay paracétamolémie to H4 when it is below the
      curve, and thus enable the return home of the patient's somatic point of view (excluding
      psychiatric care when is voluntary drug intoxication), with consequences in terms of costs
      (hospital days) and duration of treatment?
observational model: Case-Only
time perspective: Prospective
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pascal BILBAULT, MD
role: Principal Investigator
affiliation: Hôpitaux Universitaires de Strasbourg
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Drug Overdose