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

• Conditions: Heart Failure; Acute Kidney Injury
• Interventions: Diagnostic Test: Furosemide stress test

• Registration Number: NCT04464811
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2020-07
• Study Start: 2020-07-05
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Last Update Submitted: 2020-07-06
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 257

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure with diuretic resistance	Furosemide stress test	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.
Heart failure without diuretic resistance	Furosemide stress test	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.

Primary Outcome Measures

Name	Time	Method
Serum creatinine	Seventy-two hours after admission	Changes in serum creatinine from baseline

Secondary Outcome Measures

Name	Time	Method
Serum creatinine	Day 7 of hospital admission	Changes in serum creatinine from baseline
Requirement for renal replacement therapy	During hospital admission period	Renal replacement therapy is defined as any mode of dialysis or extracorporeal therapy to treat volume overload for heart failure
Length of hospital admission	During hospital admission period	Numbers of days that patients need to stay in the hospital
Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification	Day 7 and 28 after hospital admission	Heart failure stage defined by New York Heart Association (NYHA) classification
Numbers of hospital readmission	Month 1 and 3 after hospital discharge	Readmission to the hospital due to heart failure
Mortality rate	Day 7 and 28 after hospital admission	Confirmed death

Trial Locations

Locations (1)

Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand