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

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

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Acute Kidney Injury
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 257

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute heart failure who require intravenous furosemide for the treatment of lung congestion

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine	Changes in serum creatinine from baseline	Seventy-two hours after admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine	Changes in serum creatinine from baseline	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	During hospital admission period
Length of hospital admission	Numbers of days that patients need to stay in the hospital	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	Day 7 and 28 after hospital admission
Numbers of hospital readmission	Readmission to the hospital due to heart failure	Month 1 and 3 after hospital discharge
Mortality rate	Confirmed death	Day 7 and 28 after hospital admission

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Failure; Wounds and Injuries; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: MED-2563-07080 (1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No