<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/NCT04464811</url>
  </required_header>
  <id_info>
    <org_study_id>MED-2563-07080 (1)</org_study_id>
    <nct_id>NCT04464811</nct_id>
  </id_info>
  <brief_title>Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients</brief_title>
  <official_title>Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiang Mai University</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>
      This study is aim to study the changes of serum creatinine levels at 72 hours after admission&#xD;
      in patients with acute heart failure who has diuretic resistance compared to those who do not&#xD;
      have diuretic resistance from furosemide stress test&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an observational prospective study to demonstrate a prognosis of acute heart&#xD;
      failure patients who have diuretic resistance compared to those who do not have diuretic&#xD;
      resistance from furosemide stress test. The primary outcome is changes of serum creatinine&#xD;
      levels at 72 hours compared to baseline values at the time of admission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>Seventy-two hours after admission</time_frame>
    <description>Changes in serum creatinine from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>Day 7 of hospital admission</time_frame>
    <description>Changes in serum creatinine from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement for renal replacement therapy</measure>
    <time_frame>During hospital admission period</time_frame>
    <description>Renal replacement therapy is defined as any mode of dialysis or extracorporeal therapy to treat volume overload for heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital admission</measure>
    <time_frame>During hospital admission period</time_frame>
    <description>Numbers of days that patients need to stay in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification</measure>
    <time_frame>Day 7 and 28 after hospital admission</time_frame>
    <description>Heart failure stage defined by New York Heart Association (NYHA) classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of hospital readmission</measure>
    <time_frame>Month 1 and 3 after hospital discharge</time_frame>
    <description>Readmission to the hospital due to heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>Day 7 and 28 after hospital admission</time_frame>
    <description>Confirmed death</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">257</enrollment>
  <condition>Heart Failure</condition>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Heart failure with diuretic resistance</arm_group_label>
    <description>This group includes acute heart failure patients who has diuretic resistance from furosemide stress test. Furosemide stress test will be performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have received oral furosemide before. Diuretic resistance was defined as urine output &lt;250 hr at 2 hours after furosemide administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart failure without diuretic resistance</arm_group_label>
    <description>This group includes acute heart failure patients who do not have diuretic resistance from furosemide stress test. Furosemide stress test will be performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have never received oral furosemide before. Patients will be defined not to have diuretic resistance if their urine output ≥250 hr at 2 hours after furosemide administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Furosemide stress test</intervention_name>
    <description>Furosemide stress test is performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have never received oral furosemide.</description>
    <arm_group_label>Heart failure with diuretic resistance</arm_group_label>
    <arm_group_label>Heart failure without diuretic resistance</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute heart failure who require intravenous furosemide for the treatment of&#xD;
        lung congestion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Diagnosis of acute heart failure which is defined by 2 of the 3 following features:&#xD;
             ≥2+ leg edema, jugular venous pressure &gt;10 cm from physical examination or central&#xD;
             venous pressure &gt;10 mmHg, and bilateral pulmonary edema or bilateral pleural effusion&#xD;
             from chest radiography&#xD;
&#xD;
          -  Patients consent to participate into the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who receive furosemide ≥500 mg/day or hydrochlorothiazide ≥100 mg/day or&#xD;
             spironolactone ≥100 mg/day or tolvaptan of any doses&#xD;
&#xD;
          -  Patients who have systolic blood pressure &lt;100 mmHg or who need vasoactive drugs&#xD;
             inotropic agents (except dobutamine)&#xD;
&#xD;
          -  Patients with intravascular volume depletion from clinical evaluation&#xD;
&#xD;
          -  Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate &lt;15&#xD;
             ml/min/1.73 m2) or patients who receive maintenance dialysis&#xD;
&#xD;
          -  Patients who require renal replacement therapy at the time of admission&#xD;
&#xD;
          -  Patients whom diagnosed hypertrophic obstructive cardiomyopathy, severe valvular&#xD;
             stenosis or complex congenital heart disease&#xD;
&#xD;
          -  Patients with sepsis or systemic infection&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy&#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>Kajohnsak Noppakun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instructor, Division of Nephrology, Department of Internal Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kajohnsak Noppakun, MD</last_name>
    <phone>+66815953465</phone>
    <email>kajohnsak.noppakun@cmu.ac.th</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tiranun Suriya, RN</last_name>
    <phone>+66818812106</phone>
    <email>tingsuri@hotmail.co.th</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kajohnsak Noppakun, MD</last_name>
      <phone>+66815953465</phone>
      <email>kajohnsak.noppakun@cmu.ac.th</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Kajohnsak Noppakun</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Furosemide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Request for individual participant data (IPD) has to be submitted to the Institutional Review Board (IRB) of Faculty of Medicine, Chiang Mai University, Chiang Mai, THAILAND.</ipd_description>
  </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/NCT04464811
org study id: MED-2563-07080 (1)
nct id: NCT04464811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is aim to study the changes of serum creatinine levels at 72 hours after admission
      in patients with acute heart failure who has diuretic resistance compared to those who do not
      have diuretic resistance from furosemide stress test
This study is an observational prospective study to demonstrate a prognosis of acute heart
      failure patients who have diuretic resistance compared to those who do not have diuretic
      resistance from furosemide stress test. The primary outcome is changes of serum creatinine
      levels at 72 hours compared to baseline values at the time of admission.
observational model: Cohort
time perspective: Prospective
measure: Serum creatinine
time frame: Seventy-two hours after admission
description: Changes in serum creatinine from baseline
measure: Serum creatinine
time frame: Day 7 of hospital admission
description: Changes in serum creatinine from baseline
measure: Requirement for renal replacement therapy
time frame: During hospital admission period
description: Renal replacement therapy is defined as any mode of dialysis or extracorporeal therapy to treat volume overload for heart failure
measure: Length of hospital admission
time frame: During hospital admission period
description: Numbers of days that patients need to stay in the hospital
measure: Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification
time frame: Day 7 and 28 after hospital admission
description: Heart failure stage defined by New York Heart Association (NYHA) classification
measure: Numbers of hospital readmission
time frame: Month 1 and 3 after hospital discharge
description: Readmission to the hospital due to heart failure
measure: Mortality rate
time frame: Day 7 and 28 after hospital admission
description: Confirmed death
arm group label: Heart failure with diuretic resistance
description: This group includes acute heart failure patients who has diuretic resistance from furosemide stress test. Furosemide stress test will be performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have received oral furosemide before. Diuretic resistance was defined as urine output <250 hr at 2 hours after furosemide administration.
arm group label: Heart failure without diuretic resistance
description: This group includes acute heart failure patients who do not have diuretic resistance from furosemide stress test. Furosemide stress test will be performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have never received oral furosemide before. Patients will be defined not to have diuretic resistance if their urine output ≥250 hr at 2 hours after furosemide administration.
intervention type: Diagnostic Test
intervention name: Furosemide stress test
description: Furosemide stress test is performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have never received oral furosemide.
arm group label: Heart failure with diuretic resistance
arm group label: Heart failure without diuretic resistance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kajohnsak Noppakun, MD
role: Principal Investigator
affiliation: Instructor, Division of Nephrology, Department of Internal Medicine
last name: Kajohnsak Noppakun, MD
phone: +66815953465
email: kajohnsak.noppakun@cmu.ac.th
last name: Tiranun Suriya, RN
phone: +66818812106
email: tingsuri@hotmail.co.th
facility: 
status: Recruiting
contact: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Kajohnsak Noppakun
investigator title: Assistant Professor of Medicine
mesh term: Acute Kidney Injury
mesh term: Heart Failure
mesh term: Wounds and Injuries
mesh term: Furosemide
sharing ipd: Undecided
ipd description: Request for individual participant data (IPD) has to be submitted to the Institutional Review Board (IRB) of Faculty of Medicine, Chiang Mai University, Chiang Mai, THAILAND.