<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/NCT03261518</url>
  </required_header>
  <id_info>
    <org_study_id>KÜ GOKAEK 2017/1.13</org_study_id>
    <nct_id>NCT03261518</nct_id>
  </id_info>
  <brief_title>Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED</brief_title>
  <official_title>Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Suspected Ileus in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derince Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derince Training and Research Hospital</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>
      In this study, the investigators aimed to evaluate the incidence of vena cava inferior&#xD;
      diamater on ultrasound guidance of intravascular volume before diagnosis of contrast&#xD;
&#xD;
      - enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and&#xD;
      risk of developing contrast nephropathy due to contrast - enhanced CT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our work will be carried out in Kocaeli Derince Education and Research Hospital Emergency&#xD;
      Service. Patients who are scheduled to receive abdominal contrast computed tomography (CT)&#xD;
      scans in the emergency room, who are over 18 years of age, who are referred to Kocaeli&#xD;
      Derince Education and Research Hospital Emergency Department for the study, will be&#xD;
      calculated and recorded. The Mehran risk scores will be calculated and recorded in our&#xD;
      clinic. 3 ml / kg IV physiological saline (SF) is applied first and then 1 ml / kg / hr IV SF&#xD;
      is applied for at least 6 hours after shots. In addition, patients with contrasted abdominal&#xD;
      CT underwent emergency surveillance ultrasound imaging (including the measurement of the vena&#xD;
      cava diameter for evaluation of the patient's volume status). Patients who were admitted to&#xD;
      our general surgery and not followed up for at least 48 hours, patients with contrast&#xD;
      allergies, patients with renal replacement therapy, pregnancies, patients with&#xD;
      contrast-enhanced CT scans within the last 10 days, and patients not informed will not be&#xD;
      taken to the study. All Emergency Physicians will be informed about the study. Less than 100&#xD;
      mL of hypoosmolar, non-ionic contrast material will be used for all CT shots. Patients will&#xD;
      be evaluated for the development of contrast nephropathy according to biochemical assays&#xD;
      48-72 hours after CT acquisition. Physicians evaluating patients in the emergency and general&#xD;
      surgery services will be required to record blood tests that they consider necessary for&#xD;
      diagnostic and therapeutic purposes, and no extra blood will be collected for use in the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 24, 2017</start_date>
  <completion_date type="Anticipated">December 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 15, 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>Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index</measure>
    <time_frame>48 hours</time_frame>
    <description>Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index In this study, we aimed to evaluate the incidence of vena cava inferior vena cava on ultrasound guidance of intravascular volume before diagnosis of contrast-enhanced CT and to investigate the incidence and development of contrast nephropathy due to contrast-enhanced CT.</description>
  </primary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Ileus; Mechanical</condition>
  <condition>Contrast-induced Nephropathy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>inferior vena cava ultrasound</intervention_name>
    <description>Place the patient in the supine position. The degree of elevation of the head of the bed has not been shown to make a significant difference in measurements. The diameter of the IVC for calculation of the caval index should be measured 2 cm from where it enters the right atrium .An alternative way to visualize respiratory variation is to use M-mode, with the beam overlying the IVC 2 cm from the right atrium.The inspiratory and expiratory diameter can then be measured on the M-mode image, at the smallest and largest locations, respectively.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent contrast abdominal CT and were admitted to our general surgery&#xD;
             department for at least 48 hours&#xD;
&#xD;
          -  Written informed patients&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With contrast agent allergy&#xD;
&#xD;
          -  Story of renal replacement therapy&#xD;
&#xD;
          -  Contrast agent exposure within the last 10 days&#xD;
&#xD;
          -  Pregnancy&#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_contact>
    <last_name>ALI Y UYANIK, RESIDENT</last_name>
    <phone>+90 505 220 84 09</phone>
    <email>alifen_56@hotmail.com</email>
  </overall_contact>
  <reference>
    <citation>Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.</citation>
    <PMID>15939688</PMID>
  </reference>
  <reference>
    <citation>McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.</citation>
    <PMID>27659469</PMID>
  </reference>
  <reference>
    <citation>Sanaei-Ardekani M, Movahed MR, Movafagh S, Ghahramani N. Contrast-induced nephropathy: a review. Cardiovasc Revasc Med. 2005 Apr-Jun;6(2):82-8. doi: 10.1016/j.carrev.2005.07.004.</citation>
    <PMID>16263365</PMID>
  </reference>
  <reference>
    <citation>Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007. Erratum In: Ann Intern Med. 2008 Aug 5;149(3):219.</citation>
    <PMID>18283206</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derince Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ali Yusuf Uyanik</investigator_full_name>
    <investigator_title>EMERGENCY MEDICINE RESIDENT</investigator_title>
  </responsible_party>
  <keyword>ileus</keyword>
  <keyword>Contrast-induced Nephropathy</keyword>
  <keyword>vena cava inferior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
    <mesh_term>Kidney Diseases</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/NCT03261518
org study id: KÜ GOKAEK 2017/1.13
nct id: NCT03261518
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators aimed to evaluate the incidence of vena cava inferior
      diamater on ultrasound guidance of intravascular volume before diagnosis of contrast

      - enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and
      risk of developing contrast nephropathy due to contrast - enhanced CT.
Our work will be carried out in Kocaeli Derince Education and Research Hospital Emergency
      Service. Patients who are scheduled to receive abdominal contrast computed tomography (CT)
      scans in the emergency room, who are over 18 years of age, who are referred to Kocaeli
      Derince Education and Research Hospital Emergency Department for the study, will be
      calculated and recorded. The Mehran risk scores will be calculated and recorded in our
      clinic. 3 ml / kg IV physiological saline (SF) is applied first and then 1 ml / kg / hr IV SF
      is applied for at least 6 hours after shots. In addition, patients with contrasted abdominal
      CT underwent emergency surveillance ultrasound imaging (including the measurement of the vena
      cava diameter for evaluation of the patient's volume status). Patients who were admitted to
      our general surgery and not followed up for at least 48 hours, patients with contrast
      allergies, patients with renal replacement therapy, pregnancies, patients with
      contrast-enhanced CT scans within the last 10 days, and patients not informed will not be
      taken to the study. All Emergency Physicians will be informed about the study. Less than 100
      mL of hypoosmolar, non-ionic contrast material will be used for all CT shots. Patients will
      be evaluated for the development of contrast nephropathy according to biochemical assays
      48-72 hours after CT acquisition. Physicians evaluating patients in the emergency and general
      surgery services will be required to record blood tests that they consider necessary for
      diagnostic and therapeutic purposes, and no extra blood will be collected for use in the
      study.
observational model: Case-Only
time perspective: Prospective
measure: Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index
time frame: 48 hours
description: Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index In this study, we aimed to evaluate the incidence of vena cava inferior vena cava on ultrasound guidance of intravascular volume before diagnosis of contrast-enhanced CT and to investigate the incidence and development of contrast nephropathy due to contrast-enhanced CT.
intervention type: Procedure
intervention name: inferior vena cava ultrasound
description: Place the patient in the supine position. The degree of elevation of the head of the bed has not been shown to make a significant difference in measurements. The diameter of the IVC for calculation of the caval index should be measured 2 cm from where it enters the right atrium .An alternative way to visualize respiratory variation is to use M-mode, with the beam overlying the IVC 2 cm from the right atrium.The inspiratory and expiratory diameter can then be measured on the M-mode image, at the smallest and largest locations, respectively.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ALI Y UYANIK, RESIDENT
phone: +90 505 220 84 09
email: alifen_56@hotmail.com
citation: Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.
PMID: 15939688
citation: McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.
PMID: 27659469
citation: Sanaei-Ardekani M, Movahed MR, Movafagh S, Ghahramani N. Contrast-induced nephropathy: a review. Cardiovasc Revasc Med. 2005 Apr-Jun;6(2):82-8. doi: 10.1016/j.carrev.2005.07.004.
PMID: 16263365
citation: Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007. Erratum In: Ann Intern Med. 2008 Aug 5;149(3):219.
PMID: 18283206
responsible party type: Principal Investigator
investigator affiliation: Derince Training and Research Hospital
investigator full name: Ali Yusuf Uyanik
investigator title: EMERGENCY MEDICINE RESIDENT
mesh term: Ileus
mesh term: Kidney Diseases
sharing ipd: Undecided