<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/NCT04436718</url>
  </required_header>
  <id_info>
    <org_study_id>1374867-5</org_study_id>
    <nct_id>NCT04436718</nct_id>
  </id_info>
  <brief_title>Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?</brief_title>
  <official_title>Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riverside University Health System Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riverside University Health System Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart&#xD;
      failure with primary end point of acute kidney injury while in hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a&#xD;
      significant morbidity and premature mortality. Administration of intravenous (IV) diuretics&#xD;
      is largely guided by clinical judgment based on physical exam, net fluid measurement, changes&#xD;
      in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis&#xD;
      while improving symptoms, without compromising renal function. Laboratory tests demonstrating&#xD;
      hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive&#xD;
      prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from&#xD;
      inadequate predictive value. Observational studies have identified worsening renal failure&#xD;
      (WRF) in patients admitted for heart failure as an important clinical entity associated with&#xD;
      worsening clinical outcomes.&#xD;
&#xD;
      Point of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring&#xD;
      patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic&#xD;
      information obtained and interpreted at bedside that can augment and enhance the physical&#xD;
      examination. Numerous studies have examined POCUS assessment of pulmonary edema and&#xD;
      measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients&#xD;
      with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on&#xD;
      clinical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized open label controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Worsening renal failure</measure>
    <time_frame>During hospitalization typically one week</time_frame>
    <description>Serum Creatnine levels measured in mg/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>During hospitalization typically one week</time_frame>
    <description>Measured in days from initial admission to discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Acute Decompensated Heart Failure</condition>
  <arm_group>
    <arm_group_label>Daily POCUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients are assessed daily by primary care providers per usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Daily pocus exam</intervention_name>
    <description>Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments</description>
    <arm_group_label>Daily POCUS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 admitted for acute decompensated heart failure exacerbation as primary&#xD;
             admission diagnosis from Emergency department to General Medicine ward that are&#xD;
             administered diuretic therapy expected to be admitted for two days or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decline consent for study&#xD;
&#xD;
          2. If admitted and research team not available for consent and initial evaluation prior&#xD;
             within 6 hours of first diuretic administration&#xD;
&#xD;
          3. Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD)&#xD;
&#xD;
          4. Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.)&#xD;
&#xD;
          5. Patients admitted to ICU&#xD;
&#xD;
          6. Patients currently on positive pressure ventilation (BiPAP)&#xD;
&#xD;
          7. Patients discharged from the emergency department&#xD;
&#xD;
          8. Patients discharged prior to evaluation by the POCUS team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael Ulrich, MD</last_name>
    <phone>9514864640</phone>
    <email>m.ulrich@ruhealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Minho Yu, DO</last_name>
    <phone>9514864640</phone>
    <email>m.yu@ruhealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>RUHS Medical center</name>
      <address>
        <city>Moreno Valley</city>
        <state>California</state>
        <zip>92555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Ulrich</last_name>
      <phone>951-486-4640</phone>
      <email>m.ulrich@ruhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 20, 2019</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riverside University Health System Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Ulrich MD</investigator_full_name>
    <investigator_title>Associate Medical Program Director</investigator_title>
  </responsible_party>
  <keyword>Point of care ultrasound</keyword>
  <keyword>Focused cardiac ultrasound</keyword>
  <keyword>heart failure</keyword>
  <keyword>inferior vena cava</keyword>
  <keyword>POCUS</keyword>
  <keyword>CHF</keyword>
  <keyword>FCU</keyword>
  <keyword>acute heart failure</keyword>
  <keyword>decompensated heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04436718/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT04436718/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04436718
org study id: 1374867-5
nct id: NCT04436718
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart
      failure with primary end point of acute kidney injury while in hospital.
Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a
      significant morbidity and premature mortality. Administration of intravenous (IV) diuretics
      is largely guided by clinical judgment based on physical exam, net fluid measurement, changes
      in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis
      while improving symptoms, without compromising renal function. Laboratory tests demonstrating
      hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive
      prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from
      inadequate predictive value. Observational studies have identified worsening renal failure
      (WRF) in patients admitted for heart failure as an important clinical entity associated with
      worsening clinical outcomes.

      Point of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring
      patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic
      information obtained and interpreted at bedside that can augment and enhance the physical
      examination. Numerous studies have examined POCUS assessment of pulmonary edema and
      measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients
      with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on
      clinical outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized open label controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Worsening renal failure
time frame: During hospitalization typically one week
description: Serum Creatnine levels measured in mg/dL
measure: Length of stay
time frame: During hospitalization typically one week
description: Measured in days from initial admission to discharge
arm group label: Daily POCUS
arm group type: Experimental
description: Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.
arm group label: Usual care
arm group type: No Intervention
description: Patients are assessed daily by primary care providers per usual care.
intervention type: Diagnostic Test
intervention name: Daily pocus exam
description: Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments
arm group label: Daily POCUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Michael Ulrich, MD
phone: 9514864640
email: m.ulrich@ruhealth.org
last name: Minho Yu, DO
phone: 9514864640
email: m.yu@ruhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Riverside University Health System Medical Center
investigator full name: Michael Ulrich MD
investigator title: Associate Medical Program Director
mesh term: Heart Failure
sharing ipd: No
provided document: 
provided document: 