Heart FailureNCT04464811
Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients
An observational study of Heart Failure and Acute Kidney Injury, run by Chiang Mai University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Kidney Injury
- What is being tested?
- Furosemide stress test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 257 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jul 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute heart failure who require intravenous furosemide for the treatment of lung congestion
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with sepsis or systemic infection
- Pregnant women
- Patients who have history of furosemide, spironolactone or hydrochlorothiazide allergy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Kajohnsak Noppakun, MD, +66815953465, kajohnsak.noppakun@cmu.ac.th
About this study
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
Read the 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.
- Conditions
- Heart Failure, Acute Kidney Injury
- Being tested
- Furosemide stress test
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide stress testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Furosemide stress test | |
| 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. Receives: Diagnostic Test: Furosemide stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine
Changes in serum creatinine from baseline
Measured: Seventy-two hours after admission
Secondary outcomes (6)
Serum creatinine
Changes in serum creatinine from baseline
Measured: Day 7 of hospital admission
Requirement for renal replacement therapy
Renal replacement therapy is defined as any mode of dialysis or extracorporeal therapy to treat volume overload for heart failure
Measured: During hospital admission period
Length of hospital admission
Numbers of days that patients need to stay in the hospital
Measured: During hospital admission period
Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification
Heart failure stage defined by New York Heart Association (NYHA) classification
Measured: Day 7 and 28 after hospital admission
Numbers of hospital readmission
Readmission to the hospital due to heart failure
Measured: Month 1 and 3 after hospital discharge
Mortality rate
Confirmed death
Measured: Day 7 and 28 after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start5 Jul 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajohnsak Noppakun, Chiang Mai University
- Investigators
- Kajohnsak Noppakun, MD, Principal investigator, Instructor, Division of Nephrology, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464811
- Sponsor's protocol ID
- MED-2563-07080 (1)
- Status last verified
- Jul 2020
- First submitted
- 6 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04464811
- Acronym / sponsor ID
- MED-2563-07080 (1)
- Conditions
- Heart Failure, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 5 Jul 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure with diuretic resistance | – | Diagnostic Test: Furosemide stress testThis 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. |
| Heart failure without diuretic resistance | – | Diagnostic Test: Furosemide stress testThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute heart failure who require intravenous furosemide for the treatment of lung congestion
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide stress testFurosemide 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. | Diagnostic test | Heart failure with diuretic resistance, Heart failure without diuretic resistance |
Primary outcome
Serum creatinine
Time frame: Seventy-two hours after admission
Changes in serum creatinine from baseline
6 secondary outcomes
Serum creatinine
Time frame: Day 7 of hospital admission
Requirement for renal replacement therapy
Time frame: During hospital admission period
Length of hospital admission
Time frame: During hospital admission period
Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification
Time frame: Day 7 and 28 after hospital admission
Numbers of hospital readmission
Time frame: Month 1 and 3 after hospital discharge
Mortality rate
Time frame: Day 7 and 28 after hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kajohnsak Noppakun, MD principal investigator
Instructor, Division of Nephrology, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Acute Kidney Injury, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kajohnsak Noppakun, MD (+66815953465, kajohnsak.noppakun@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine (time frame: Seventy-two hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.