Clinical trial NCT04464811: Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients
Official title: Furosemide Stress Test for the Prediction of Acute Kidney Injury Severity in Acute Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Acute Kidney Injury
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute heart failure who require intravenous furosemide for the treatment of lung congestion

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

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.

Eligibility 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

Primary outcomes:
measure: Serum creatinine
timeFrame: Seventy-two hours after admission
Secondary outcomes:
measure: Serum creatinine
timeFrame: Day 7 of hospital admission
measure: Requirement for renal replacement therapy
timeFrame: During hospital admission period
measure: Length of hospital admission
timeFrame: During hospital admission period
measure: Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification
timeFrame: Day 7 and 28 after hospital admission
measure: Numbers of hospital readmission
timeFrame: Month 1 and 3 after hospital discharge
measure: Mortality rate
timeFrame: Day 7 and 28 after hospital admission
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Instructor, Division of Nephrology, Department of Internal Medicine
name: Kajohnsak Noppakun, MD
role: PRINCIPAL_INVESTIGATOR
References: