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

NCT04464811 | Unknown

• 1 other identifier: MED-2563-07080 (1)
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Serum creatinine

  Changes in serum creatinine from baseline

  Seventy-two hours after admission

Secondary Outcomes (6)

• Serum creatinine

  Day 7 of hospital admission

• Requirement for renal replacement therapy

  During hospital admission period

• Length of hospital admission

  During hospital admission period

• Changes of the stage of heart failure defined by New York Heart Association (NYHA) classification

  Day 7 and 28 after hospital admission

• Numbers of hospital readmission

  Month 1 and 3 after hospital discharge

Study Arms (2)

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

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

Interventions

Furosemide stress test DIAGNOSTIC_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 with diuretic resistance; Heart failure without diuretic resistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kajohnsak Noppakun, MD

  Instructor, Division of Nephrology, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kajohnsak Noppakun, MD

CONTACT

+66815953465; kajohnsak.noppakun@cmu.ac.th

Tiranun Suriya, RN

CONTACT

+66818812106; tingsuri@hotmail.co.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: July 5, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

TH (1)