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Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464811
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kajohnsak Noppakun, Chiang Mai University

Brief Summary:
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

Condition or disease Intervention/treatment
Heart Failure Acute Kidney Injury Diagnostic Test: Furosemide stress test

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 257 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients
Actual Study Start Date : July 5, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Group/Cohort Intervention/treatment
Heart failure with diuretic resistance
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.
Diagnostic Test: Furosemide stress test
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.

Heart failure without diuretic resistance
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.
Diagnostic Test: Furosemide stress test
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.




Primary Outcome Measures :
  1. Serum creatinine [ Time Frame: Seventy-two hours after admission ]
    Changes in serum creatinine from baseline


Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: Day 7 of hospital admission ]
    Changes in serum creatinine from baseline

  2. Requirement for renal replacement therapy [ Time Frame: During hospital admission period ]
    Renal replacement therapy is defined as any mode of dialysis or extracorporeal therapy to treat volume overload for heart failure

  3. Length of hospital admission [ Time Frame: During hospital admission period ]
    Numbers of days that patients need to stay in the hospital

  4. Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification [ Time Frame: Day 7 and 28 after hospital admission ]
    Heart failure stage defined by New York Heart Association (NYHA) classification

  5. Numbers of hospital readmission [ Time Frame: Month 1 and 3 after hospital discharge ]
    Readmission to the hospital due to heart failure

  6. Mortality rate [ Time Frame: Day 7 and 28 after hospital admission ]
    Confirmed death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute heart failure who require intravenous furosemide for the treatment of lung congestion
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of acute heart failure which is defined by 2 of the 3 following features: ≥2+ leg edema, jugular venous pressure >10 cm from physical examination or central venous pressure >10 mmHg, and bilateral pulmonary edema or bilateral pleural effusion from chest radiography
  • Patients consent to participate into the study

Exclusion Criteria:

  • Patients who receive furosemide ≥500 mg/day or hydrochlorothiazide ≥100 mg/day or spironolactone ≥100 mg/day or tolvaptan of any doses
  • Patients who have systolic blood pressure <100 mmHg or who need vasoactive drugs inotropic agents (except dobutamine)
  • Patients with intravascular volume depletion from clinical evaluation
  • Patients with chronic kidney disease stage 5 (estimated glomerular filtration rate <15 ml/min/1.73 m2) or patients who receive maintenance dialysis
  • Patients who require renal replacement therapy at the time of admission
  • Patients whom diagnosed hypertrophic obstructive cardiomyopathy, severe valvular stenosis or complex congenital heart disease
  • Patients with sepsis or systemic infection
  • Pregnant women
  • Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464811


Contacts
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Contact: Kajohnsak Noppakun, MD +66815953465 kajohnsak.noppakun@cmu.ac.th
Contact: Tiranun Suriya, RN +66818812106 tingsuri@hotmail.co.th

Locations
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Thailand
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Contact: Kajohnsak Noppakun, MD    +66815953465    kajohnsak.noppakun@cmu.ac.th   
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Kajohnsak Noppakun, MD Instructor, Division of Nephrology, Department of Internal Medicine
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Responsible Party: Kajohnsak Noppakun, Assistant Professor of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT04464811    
Other Study ID Numbers: MED-2563-07080 (1)
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action