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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464811
• Other study ID #: MED-2563-07080 (1)
• Status: Recruiting
• Start date: July 5, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2020
• Source: Chiang Mai University
• Contact: Kajohnsak Noppakun, MD
• Phone: +66815953465
• Email: kajohnsak.noppakun[@]cmu.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 257
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Failure
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Thailand	Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine	Changes in serum creatinine from baseline	Seventy-two hours after admission
Secondary	Serum creatinine	Changes in serum creatinine from baseline	Day 7 of hospital admission
Secondary	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
Secondary	Length of hospital admission	Numbers of days that patients need to stay in the hospital	During hospital admission period
Secondary	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
Secondary	Numbers of hospital readmission	Readmission to the hospital due to heart failure	Month 1 and 3 after hospital discharge
Secondary	Mortality rate	Confirmed death	Day 7 and 28 after hospital admission