<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/NCT03762057</url>
  </required_header>
  <id_info>
    <org_study_id>CK999</org_study_id>
    <nct_id>NCT03762057</nct_id>
  </id_info>
  <brief_title>Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital</brief_title>
  <official_title>Prevalence, Risk Factors, and Prognostic Factors of Intraabdominal Hypertension and Abdominal Compartment Syndrome in Critically Ill Surgical Patients in Ramathibodi Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ramathibodi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ramathibodi 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>
      To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical&#xD;
      critically ill patients in institutional hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be&#xD;
      asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured&#xD;
      through already placed Foley's catheter simultaneously with patients's data record. If&#xD;
      patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or&#xD;
      removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8&#xD;
      hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU&#xD;
      or removal of Foley's catheter. After completion of data collection, data will be analyzed&#xD;
      accordingly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 10, 2018</start_date>
  <completion_date type="Anticipated">June 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2019</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>30 Days</target_duration>
  <primary_outcome>
    <measure>Prevalence of intraabdominal hypertension and abdominal compartment syndrome</measure>
    <time_frame>Within 30 days of ICU admission</time_frame>
    <description>Prevalence of intraabdominal hypertension and abdominal compartment syndrome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors of intraabdominal hypertension and abdominal compartment syndrome</measure>
    <time_frame>Within 30 days of ICU admission</time_frame>
    <description>Risk factors of intraabdominal hypertension and abdominal compartment syndrome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome</measure>
    <time_frame>Within 30 days of ICU admission</time_frame>
    <description>Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">303</enrollment>
  <condition>Intraabdominal Hypertension</condition>
  <condition>Abdominal Compartment Syndrome</condition>
  <arm_group>
    <arm_group_label>Surgical patients</arm_group_label>
    <description>All postoperative patients admitted to surgical ICU with foley catheter in place</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Intraabdominal pressure monitoring</intervention_name>
    <description>Classic manometry technique measurement once daily</description>
    <arm_group_label>Surgical patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All postoperative adult patients admitted to institutional surgical ICUs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postoperative patient admitted to surgical ICU&#xD;
&#xD;
          -  Age &gt;/= 18&#xD;
&#xD;
          -  Foley's catheter in place&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Underwent neo-bladder procedure&#xD;
&#xD;
          -  Need continuous bladder irrigation&#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>Cherdkiat Karnjanarachata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of medicine, Ramathibodi Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cherdkiat Karnjanarachata, MD</last_name>
    <phone>+66-85-5774747</phone>
    <email>chird_na@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kittikhun Narkasawet, MD</last_name>
    <phone>+66-81-6820808</phone>
    <email>konkengsood@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ramathibodi Hospital</name>
      <address>
        <city>Ratchathewi</city>
        <state>Bangkok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <contact>
      <last_name>Cherdkiat Karnjanarachata, MD</last_name>
      <phone>+66-85-5774747</phone>
      <email>chird_na@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Cherdkiat Karnjanarachata, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ramathibodi Hospital</investigator_affiliation>
    <investigator_full_name>Cherdkiat karnjanarachata</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Intraabdominal Hypertension</keyword>
  <keyword>Abdominal Compartment Syndrome</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Risk factors</keyword>
  <keyword>ICU</keyword>
  <keyword>Surgical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compartment Syndromes</mesh_term>
    <mesh_term>Intra-Abdominal Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03762057
org study id: CK999
nct id: NCT03762057
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To identified prevalence, risk factors, and prognostic factors of IAH and ACS in surgical
      critically ill patients in institutional hospital
Every postoperative patients admitted to surgical ICU who meet inclusion criteria will be
      asked for informed consent. After obtained, intraabdominal pressure (IAP) will be measured
      through already placed Foley's catheter simultaneously with patients's data record. If
      patients don't have IAH or ICS, IAP will be measured daily until discharge from ICU or
      removal of Foley's catheter. If patients have IAH or ACS, IAP will be measured every 6-8
      hours until IAP is less than 12 mmHg then it will be measures daily until discharge from ICU
      or removal of Foley's catheter. After completion of data collection, data will be analyzed
      accordingly.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of intraabdominal hypertension and abdominal compartment syndrome
time frame: Within 30 days of ICU admission
description: Prevalence of intraabdominal hypertension and abdominal compartment syndrome
measure: Risk factors of intraabdominal hypertension and abdominal compartment syndrome
time frame: Within 30 days of ICU admission
description: Risk factors of intraabdominal hypertension and abdominal compartment syndrome
measure: Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
time frame: Within 30 days of ICU admission
description: Prognostic factors of death after developing intraabdominal hypertension and abdominal compartment syndrome
arm group label: Surgical patients
description: All postoperative patients admitted to surgical ICU with foley catheter in place
intervention type: Diagnostic Test
intervention name: Intraabdominal pressure monitoring
description: Classic manometry technique measurement once daily
arm group label: Surgical patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cherdkiat Karnjanarachata, MD
role: Principal Investigator
affiliation: Faculty of medicine, Ramathibodi Hospital
last name: Cherdkiat Karnjanarachata, MD
phone: +66-85-5774747
email: chird_na@yahoo.com
last name: Kittikhun Narkasawet, MD
phone: +66-81-6820808
email: konkengsood@hotmail.com
facility: 
contact: 
investigator: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Ramathibodi Hospital
investigator full name: Cherdkiat karnjanarachata
investigator title: MD
mesh term: Compartment Syndromes
mesh term: Intra-Abdominal Hypertension
mesh term: Hypertension
mesh term: Syndrome
sharing ipd: No