<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/NCT03019341</url>
  </required_header>
  <id_info>
    <org_study_id>SeoulNUH_NVICM</org_study_id>
    <nct_id>NCT03019341</nct_id>
  </id_info>
  <brief_title>Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media</brief_title>
  <official_title>Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media: Prevalence and Risk Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of nausea and vomiting after the administration of non-ionic contrast media&#xD;
      has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk&#xD;
      factors of nausea and vomiting after the exposure to the non-ionic contrast media for&#xD;
      computed tomography examinations in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in&#xD;
      patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT&#xD;
      worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess&#xD;
      the prevalence and the risk factors for nausea and vomiting after the exposure to the&#xD;
      non-ionic contrast media agent in adult patients undergoing computed tomography examinations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Prevalence of immediate nausea or vomiting after contrast injection</measure>
    <time_frame>For 30 minutes after administration of non-ionic contrast media</time_frame>
    <description>Patients will be observed for 30 minutes after the administration of the contrast media agent and medical staffs will record and evaluate the patients' status and the severity of gastrointestinal reaction to the contrast media agent such as nausea or vomiting.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1175</enrollment>
  <condition>Contrast Agent</condition>
  <condition>Nausea</condition>
  <arm_group>
    <arm_group_label>Patients with enhanced CT scan</arm_group_label>
    <description>Patients undergo CT examination after the administration of non-ionic contrast media for clinical need.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who undergo elective CT examination after the administration of non-ionic contrast&#xD;
        media in a single tertiary hospital will be enrolled based on following inclusion and&#xD;
        exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients undergoing contrast-enhanced CT examination with non-ionic contrast media&#xD;
             during regular working hours&#xD;
&#xD;
          -  Adult patients (20 years old or older)&#xD;
&#xD;
          -  Patients with informed written consent&#xD;
&#xD;
          -  Patients under observation by medical staffs during and after CT examination up to 30&#xD;
             minutes.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients without informed written consent&#xD;
&#xD;
          -  Age of patients younger than 20 years old&#xD;
&#xD;
          -  Uncooperative patients&#xD;
&#xD;
          -  Pediatric, pregnant, and emergent patients&#xD;
&#xD;
          -  Patients without sufficient observation by medical staffs during and after CT&#xD;
             examination up to 30 minutes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soon ho Yoon</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University of Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Lee BY, Ok JJ, Abdelaziz Elsayed AA, Kim Y, Han DH. Preparative fasting for contrast-enhanced CT: reconsideration. Radiology. 2012 May;263(2):444-50. doi: 10.1148/radiol.12111605.</citation>
    <PMID>22517959</PMID>
  </reference>
  <reference>
    <citation>Federle MP, Willis LL, Swanson DP. Ionic versus nonionic contrast media: a prospective study of the effect of rapid bolus injection on nausea and anaphylactoid reactions. J Comput Assist Tomogr. 1998 May-Jun;22(3):341-5. doi: 10.1097/00004728-199805000-00001.</citation>
    <PMID>9606371</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Soon Ho Yoon</investigator_full_name>
    <investigator_title>Assistant professor, Department of Radiology, Seoul National University Hospital</investigator_title>
  </responsible_party>
  <keyword>Nausea</keyword>
  <keyword>Vomiting</keyword>
  <keyword>Non-ionic contrast media</keyword>
  <keyword>Side effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</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/NCT03019341
org study id: SeoulNUH_NVICM
nct id: NCT03019341
lead sponsor: 
has dmc: No
The prevalence of nausea and vomiting after the administration of non-ionic contrast media
      has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk
      factors of nausea and vomiting after the exposure to the non-ionic contrast media for
      computed tomography examinations in adults.
There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in
      patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT
      worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess
      the prevalence and the risk factors for nausea and vomiting after the exposure to the
      non-ionic contrast media agent in adult patients undergoing computed tomography examinations.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of immediate nausea or vomiting after contrast injection
time frame: For 30 minutes after administration of non-ionic contrast media
description: Patients will be observed for 30 minutes after the administration of the contrast media agent and medical staffs will record and evaluate the patients' status and the severity of gastrointestinal reaction to the contrast media agent such as nausea or vomiting.
arm group label: Patients with enhanced CT scan
description: Patients undergo CT examination after the administration of non-ionic contrast media for clinical need.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Soon ho Yoon
role: Study Chair
affiliation: Seoul National University of Hospital
facility: 
country: Korea, Republic of
citation: Lee BY, Ok JJ, Abdelaziz Elsayed AA, Kim Y, Han DH. Preparative fasting for contrast-enhanced CT: reconsideration. Radiology. 2012 May;263(2):444-50. doi: 10.1148/radiol.12111605.
PMID: 22517959
citation: Federle MP, Willis LL, Swanson DP. Ionic versus nonionic contrast media: a prospective study of the effect of rapid bolus injection on nausea and anaphylactoid reactions. J Comput Assist Tomogr. 1998 May-Jun;22(3):341-5. doi: 10.1097/00004728-199805000-00001.
PMID: 9606371
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Soon Ho Yoon
investigator title: Assistant professor, Department of Radiology, Seoul National University Hospital
mesh term: Nausea
mesh term: Vomiting
sharing ipd: Undecided